1,345 Results for

Regulatory Affairs Jobs in Brookline, MA

Jobs

New!

Cambridge, MA4 days ago

This role will outline business processes, define the dataflow, analyze options among existing and new tools, and facilitate prioritization and simplification in providing the feasible solutions to achieve short- and long-term business goals. Communicate to project stakeholders, users, project managers and other project members throughout the project lifecycle changes and system enhancements to ensure that the business requirements, issues and solutions are understood.

New!

Cambridge, MA4 days ago

$220–$320 Per Hour

This is an opportunity to provide clinical leadership in developing RNAi therapeutics, rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology. While the primary focus responsibility will be as clinical lead physician on client's autoimmune liver disease programs, the role may support across a range of therapeutic areas and all stages of development may be required as pipeline assets evolve.

New!

Cambridge, MA4 days ago

$220–$320 Per Hour

This is an opportunity to provide clinical leadership in developing RNAi therapeutics in client's rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology. The Senior Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies.

New!

Boston, MA1 day ago

Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws.

New!

Boston, MA5 days ago

li>Strong hands-on knowledge of LAN/WAN protocols and technologies including Carrier Ethernet, T1, DS3, optical, DWDM, NTP, Spanning Tree, VLAN's, 802.1q, VFR, LFA, SMTP, SNMP v1-v3, OSPF, BGP, MPLS, VPLS, Ethernet, TCP/IP, SSL, SSH, SIP, H.323, QoS, Multicast, Anycast, 802.1x, Radius, NAC, DHCP, DNS, F5 Wide-IP, VRRP, HSRP, GLBP, PBR, VPC, LACP, SGT, SGACL, SXP, VxLAN, OTP, LISP, SPAN, WCCP, PfR, IPSLA, iWAN, VPN, IPSec, Wi-Fi 6, 6E, 7.

Proven experience and success with planning, installing and managing networks including LAN, MAN, WAN, Optical Networking, DWDM, Wi-Fi, Silverpeak SDWAN or Riverbed WAN Optimizers, F5 Load Balancers, F5 GTM Global Traffic Manager, Cisco Catalyst Center, and security (firewalls, VPN, DMZ, IDS/IPS, WebProxy, content filter, FireEye, NAC and Cisco TrustSec) infrastructure.

Boston, MA30+ days ago

$190,800–$300,300 Per Year

p>Required Skills:

Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.

Boston, MA16 days ago

$170,000–$220,000 Per Year

p>At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.

Partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features, algorithms, health insights, claims, intended uses, and user experiences, and recommend appropriate regulatory and claims strategies.

Ayer, Massachusetts13 days ago

The employee will on occasion be required to enter the warehouse, lab, and/or production environment requiring the use of personal protective equipment such as safety shoes, safety glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines.

Joining ACI means becoming part of a diverse team of talented people who want to build their careers while contributing back to society in a positive way.

Ayer, Massachusetts13 days ago
The employee will on occasion be required to enter the warehouse, lab, and/or production environment requiring the use of personal protective equipment such as safety shoes, safety glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines.
Joining ACI means becoming part of a diverse team of talented people who want to build their careers while contributing back to society in a positive way.

New!
Ayer, MA3 days ago
Ability to sit for extended periods, perform visual inspections of labels/documents, occasional lifting up to 25 lbs., standing/walking/bending as needed. Perform regulatory research, document reviews, label proofreading, version control, and cross-functional coordination to enable compliant product release.

Waltham, MA30+ days ago
p>Reporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to-day regulatory activities for product development and approval in alignment with the corporate strategy for Viridian's Thyroid Eye Disease (TED) and TSHR portfolio.
Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Regulatory CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions.

New!
Cambridge, MA5 days ago
$170,900–$231,300 Per Year
Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on US regulatory requirements, and interpreting regulatory intelligence for the internal teams.
Serve as member of/or lead the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.

Marlborough, MA30+ days ago
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Your responsibilities will include: Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed.

South Boston, MA13 days ago
$165,000–$180,000 Per Year
The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.

Billerica, MA18 days ago
$182,100–$273,100 Per Year
Your Role: The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company core data sheets (CCDS), regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]) and target product labels, in line with target product profiles and overall program goals. About SpringWorks Therapeutics: SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with rare tumors.

Waltham, MA19 days ago
$138,750–$231,250 Per Year
This role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Site Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, USA - Maryland - Rockville, USA - Massachusetts - Waltham Posted Date: Jun 9 2026 Associate Director Regulatory Affairs, Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.

Waltham, MA30+ days ago
$210,000–$270,000 Per Year
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Oversees and leads the Regulatory Affairs function to ensure global regulatory requirements are met for Nova products including but not limited to: U.S. FDA 21 CFR Part 820 (Quality Management System Regulation (QMSR), ISO 13485:2016,; EU Regulation (EU) 2017/746 (IVDR); UK Medical Devices Regulations 2002 (UK MDR 2002); Australian Therapeutic Goods (Medical Devices) Regulations 2002 (incl. Reggiannini%40aicompanies.com%7Cf6fba6f305dd4f5db48208dd4cfb41b1%7Cef83c7bf14e34752af743ef60a50e893%7C0%7C0%7C638751364205790035%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=EsnZO9uH6fllGdFfgcxIXEsPp3qEXFI%2FT5rnvjqL6MU%3D&reserved=0" rel="nofollow noopener noreferrer" target="_blank">https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW.

Burlington, MA30+ days ago
p>This role requires a strong ability to translate evolving regulatory requirementssuch as EU MDR 2017/745into clear, actionable plans, while partnering cross-functionally to align regulatory expectations with fast-paced product and software development cycles.
In addition to its medical imaging products, Butterfly Embedded is the Companys Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond.

Waltham, California18 days ago
Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.

Boston, MA21 days ago
p>This role requires a strong ability to translate evolving regulatory requirements—such as EU MDR 2017/745—into clear, actionable plans, while partnering cross-functionally to align regulatory expectations with fast-paced product and software development cycles.
In addition to its medical imaging products, Butterfly Embedded is the Company's Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond.

Watertown, MA19 days ago
These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development.
Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer.

Boston, MA10 days ago
$218,058–$327,087 Per Year
p>Accountabilities:
Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs.
Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.

Boston, Massachusetts30+ days ago
Overview:
Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology.
Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.

MA23 days ago
$170,900–$231,300 Per Year
Lead or help to lead the interpretation of regulatory expectations for emerging modalities, including oligonucleotide therapeutics, conjugated delivery systems (e.g., GalNAc and other targeting ligands), antibody-drug conjugates, peptide conjugates, and biologic or hybrid modalities. This role serves as a key bridge between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences, helping to translate evolving science into effective global regulatory CMC strategies.

MA30+ days ago
$255,800–$402,700 Per Year
em> 10% Travel Required Skills: Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, Chemistry, Collaborative Development, Confidentiality, Cross-Cultural Awareness, Decision Making, Electronic Common Technical Document (eCTD), Executive Management, Mentoring Staff, People Leadership, Pharmaceutical Sciences, Professional Networking, Project Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance Audits, Regulatory Development, Regulatory Monitoring, Regulatory Reporting, Regulatory Risk, Regulatory Submissions, Risk Analysis {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply.

Boston, MA30+ days ago
$102,330–$125,070 Per Year
An employee's pay position within the salary range will be based on several factors including, but limited to, relevant education, qualifications, certifications, experience, skills, performance, shift, travel requirements, sales or revenue-based metrics, and business or organizational needs and affordability. Learn how we are dedicated to creating an inclusive and rewarding workplace that promotes excellence and provides opportunities for employees to forge their unique career path by visiting our Company Culture page.

Boston, MA30+ days ago
$231,900–$365,000 Per Year
p>Required Skills:
Accountability, Accountability, Business Development, Communication, Complaint Management, Cross-Cultural Awareness, External Communication, Global Health, Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology, People Management, Pharmaceutical Regulatory Affairs, Professional Integrity, Project Resource Allocation, Project Tasks, R&D Strategy, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Resource Allocation {+ 3 more}.
Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects, partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.

South Boston, Massachusetts13 days ago
The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.

MA30+ days ago
Lead the client's internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities. In this consultative role, you will combine regulatory expertise, analytical rigor, and strong project leadership skills to navigate an evolving regulatory landscape while collaborating closely with clients, internal experts, and global teams.

Cambridge, MA30+ days ago
$160,000–$185,000 Per Year
Responsibilities: Participates as a regulatory representative for Clinical Study Team (CST) on development programs assigned working closely with product development team (PDT) lead to develop the global regulatory strategy; work closely with regulatory operations and program management to track timelines and ensure deliverables are achieved. Manage regulatory submission processes, develop and maintain regulatory tracking tools and infrastructure, as assigned Conduct regulatory intelligence and competitive intelligence and summarize key impacts to global strategy development teams, as appropriate.

Waltham, MA22 days ago
$161,000–$187,000 Per Year
Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.

Boston, MA20 days ago
$260,000–$360,000 Per Year
p>This leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams.
Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.

Boston, MA30+ days ago
Remote
$171,000–$204,000 Per Year
p>We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51).

Beverly, MA30+ days ago
$96,000–$192,000 Per Year
In this strategic individual contributor role, the Regulatory Affairs & Compliance Lead collaborates cross-functionally with Product Development, Quality, Manufacturing, Marketing, Legal, and Compliance teams to ensure regulatory alignment and market readiness.
The Regulatory Affairs & Compliance Lead leads the development and execution of global regulatory strategies, manage submissions and regulatory changes, and support product launches across international markets.

Boston, Massachusetts30+ days ago
div>
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.
Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

Cambridge, MA30+ days ago
Remote
$193,176–$236,104 Per Year
This role works closely with commercial/launch teams, medical affairs, research and development, corporate communications, and legal to ensure external communications, including but not limited to promotional communications, are compliant with regulatory requirements and align with strategic objectives and commercial regulatory strategy.
Represents Regulatory on the Commercial Medical, Legal, Regulatory Committee (CMLR) to navigate claims and presentations, providing advice based on the Federal Food, Drug, & Cosmetic Act (FDCA) and implementing regulations impacting advertising & promotional labeling.

Boston, MA24 days ago
$160,000–$240,000 Per Year
For the right candidate, this role offers significant growth potential as you help shape the regulatory future of our rare disease programs and make a meaningful impact on patients lives. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.

Waltham, MA30+ days ago
Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands.
This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.

Boston, Massachusetts18 days ago
Remote
p>We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51).

Boston, MA30+ days ago
$153,600–$241,340 Per Year
Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the teams delivery of critical functions as follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.

Boston, Massachusetts30+ days ago
p style="margin:0px">Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration.
Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.

Boston, Massachusetts21 days ago
li class="TableParagraph" style="margin-left:8px">Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity. This leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams.

Needham, Massachusetts30+ days ago
Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

Somerville, Massachusetts30+ days ago
$133,000–$165,000 Per Year
li style="border:none;margin:3pt 0in 3pt 0.5in">Lead and manage regulatory submissions, including FDA Q-submission, US 510(k)s submissions, Premarket Approvals (PMA) submissions, supplements, and reports, including Regulatory Body interactions.
Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for high risk medical devices.

Massachusetts18 days ago
Remote
div>
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.
Partner with local/regional regulatory representatives to lead and support lifecycle management regulatory activities for the digital health and precision medicine portfolio, including change impact assessments, regulatory strategy alignment, and execution of required maintenance submissions/notifications to ensure ongoing compliance across markets.

Boston, MA30+ days ago
$60,315–$85,192.50 Per Year
p>The fellow will have the opportunity to work collaboratively with other functional areas within Ironwood, including global patient safety, clinical development, medical scientific affairs, program management, data sciences, quality and compliance, nonclinical, medical writing and publications, and chemistry, manufacturing, and controls, as well as experience partner interactions and engage in vendor oversight.
Responsibilities:
The purpose of the Regulatory Affairs (RA) Fellowship is to provide the fellow with training in the functional area and to prepare them to enter an industry role as an individual contributor in Global Regulatory Affairs after the end of their 2-year fellowship.

Boston, MA9 days ago
$90,000–$125,000 Per Year
Full-time
p>Our client, a clinical-stage biotechnology company based in Boston's Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team. The position reports directly to the VP of Regulatory Affairs and works closely with cross-functional teams including R&D, clinical operations, and quality assurance.

Boston, Massachusetts30+ days ago
FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients.
Develop and execute integrated global regulatory strategies to advance investigational oncology assets from early development through approval and lifecycle management, partnering closely with the VP, Regulatory Affairs.

Cambridge, MA30+ days ago
$144,400–$195,400 Per Year
em> Helps to lead the interpretation of regulatory expectations for emerging modalities, including: siRNA and oligonucleotide therapeutics Conjugated delivery systems (e.g., GalNAc and other targeting ligands including biologic modalities) Complex drug substance and drug product configurations Helps to assess CMC implications of new technologies and modalities, including: Impact on product characterization, control strategies, and specifications Regulatory classification considerations (e.g., small-molecule vs biologic paradigms) Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments. Broad understanding of: Drug substance and drug product development Analytical characterization and control strategies Regulatory framework across major regions (e.g., US, EU, Japan, China) Strong ability to integrate scientific, technical, and regulatory considerations into clear strategies #LI-KB1 #LI-Hybrid U.S. Pay Range $144,400.00 - $195,400.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting.

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Regulatory Affairs Jobs in Brookline, MA

Principal IT Business Analyst - Contract TalentBurst, Inc.

Senior Medical Director, Clinical Research - Hepatology - 6 TalentBurst, Inc.

Senior Medical Director, Clinical Research - Neurodegeneration - 6 TalentBurst, Inc.

Clinical Educator Inizio Engage

Sr. Network Architect ECLARO

Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co Inc

Staff Regulatory Affairs Associate (Digital Health & AI Technologies) Whoop Inc

Regulatory Affairs Associate Ajinomoto Cambrooke, Inc.

Regulatory Affairs Associate Ajinomoto Health & Nutrition North America, Inc.

Regulatory Affairs Associate:$71,449+ YR Ajinomoto Cambrooke, Inc.

Associate Director Regulatory Affairs Viridian Therapeutics Inc

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

Senior Regulatory Affairs Specialist Boston Scientific Corp

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AG

Director, Global Labeling - Regulatory Affairs SpringWorks Therapeutics Inc

Associate Director Regulatory Affairs, Oncology GSK plc

Director, Regulatory Affairs Nova Biomedical

Senior International Regulatory Affairs Specialist Butterfly Network Inc

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics

Senior International Regulatory Affairs Specialist Butterfly Network

VP or SVP, Regulatory Affairs Acrivon Therapeutics Inc

Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca Plc

Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, Inc

Associate Director Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

Executive Director, Regulatory Affairs Merck & Co Inc

Policy Manager, Government and Regulatory Affairs Blue Cross and Blue Shield of Massachusetts Inc

Executive Director, Regulatory Affairs Liaison Merck & Co Inc

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics

Senior Regulatory Affairs Consultant - Regulatory Intelligence (Talent Pool) Parexel International Corp

Senior Manager, Regulatory Affairs Nuvalent Inc

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics Inc

Vice President, Regulatory Affairs Rhythm Pharmaceuticals Inc

Associate Director, Regulatory Affairs Entrada Therapeutics Inc

Regulatory Affairs & Compliance Lead Carrier Corporation

Associate Director, Global Regulatory Affairs - GI & Inflammation Takeda

Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL) Intellia Therapeutics Inc

Associate Director, Regulatory Affairs Rhythm Pharmaceuticals Inc

Regulatory Affairs Manager Dentsply Sirona Inc

Associate Director, Regulatory Affairs Entrada Therapeutics

Associate Director, Global Regulatory Affairs CMC Takeda Pharmaceutical Co Ltd

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Vice President, Regulatory Affairs Rhythm Pharmaceuticals

Director, Regulatory Affairs, Commercial (Advertising & Promotion) Xenon Pharmaceuticals

Sr Regulatory Affairs Principal Autonomous Deephealth

Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health Takeda

Postdoctoral Research Fellow-Ironwood Pharmaceuticals, Regulatory Affairs Northeastern University

Regulatory Affairs Specialist Careerscape

Senior Director, Regulatory Affairs Bicara Therapeutics

Sr. Manager Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

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