1,576 Results for

Regulatory Affairs Jobs in Westwood, MA

Jobs

Principal Customer Solutions Architect, Ads Regulatory Compliance Microsoft

Boston, MA

$142,800–$274,800 / year

As the Principal Customer Solutions Architect, Ads Regulatory Compliance, you will operate at the intersection of product, engineering, policy, legal, operations, and business strategy to translate emerging regulatory requirements into scalable frameworks, governance models, and solution architectures. There is a different range applicable to specific work locations, within the San Francisco Bay area and New York City metropolitan area, and the base pay range for this role in those locations is USD $188,000 - $304,200 per year.

6 days ago

Manager, Regional Regulatory Lead - LCM CSL

Waltham, MA

$129,000–$153,000 / year

Developing regional knowledge regarding health authority requirements, regulatory filing pathway/categories, processes, and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders (e.g., GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new, and marketed products. Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes.

6 days ago

Director, Global Trade Waters Corporation

Milford, MA

The Director, Global Trade Compliance & Trade Operations is a senior enterprise leader responsible for defining and advancing the company’s global trade strategy, integrating regulatory compliance with world-class import/export operations. This role operates at the intersection of risk governance and supply chain execution, ensuring the organization can scale globally while maintaining strict adherence to international trade laws.

Today

Sr. Network Architect ECLARO

Boston, MA

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.

3 days ago

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

Boston, MA

$190,800–$300,300 / year

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.

30+ days ago

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

Boston, Massachusetts

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.

30+ days ago

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

Boston, MA

$170,000–$220,000 / year

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.

30+ days ago

Associate Director Regulatory Affairs Viridian Therapeutics Inc

Waltham, MA

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.

30+ days ago

Director of Regulatory Affairs, Post-Market Compliance Werfen

Bedford, Massachusetts

$200,000–$240,000 / year
Full time

Reporting to the Senior Director of Regulatory Affairs, this position is responsible for ensuring worldwide regulatory compliance of commercially distributed products through effective management of vigilance reporting, field actions, post-market surveillance activities, regulatory assessments, and product lifecycle compliance programs. The Director serves as the regulatory leader for post-market compliance activities and collaborates closely with Quality Assurance, Medical Affairs, R&D, Operations, Manufacturing, Supply Chain, and Commercial teams to ensure timely identification, assessment, communication, and resolution of product-related regulatory issues.

13 days ago

Manager, Regulatory Affairs Program Canadian Nuclear Laboratories Ltd

Burlington, MA

Managing the work of and leading technical specialists within the Branch, elsewhere within CNL, and external to CNL (as required) to ensure that requests for independent technical review of technical documentation submitted by Proponents, or requests by Proponents for independent review of activities at nuclear facilities at CNL sites, are accommodated and dispositioned effectively and efficiently with due regard to timely review while maintaining technical breadth and depth and not compromising safety. In consultation with the SRC Secretariat and Proponents, planning independent technical reviews, accepting hazard categories following the review of proposals by Proponents, liaising with the NCS Panel Chair and the NCS Panel Technical Secretary, chairing SRC independent technical review meetings, and ensuring that final review comments that are compiled from SRC technical reviewers are consistent and harmonized before they are sent to the Proponents.

25 days ago

Assoc. Director, Regulatory Affairs Advertising and Promotion Definium Therapeutics Inc

Boston, MA

$160,000–$190,000 / year

Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Provides input into labeling strategies for investigational and marketed products and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s).

30 days ago

Associate Director / Director, Regulatory Affairs Treeline Biosciences, Inc.

Watertown, MA

$175,000–$206,015 / year

Contribute to (Associate Director) or hold final accountability for (Director) regulatory documentation, ensuring adherence to FDA and other global health authority specifications and timelines, including submissions, correspondence, and approvals, and ensuring accurate and organized records. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes.

30+ days ago

Associate Director / Director, Regulatory Affairs Treeline Biosciences Inc

Watertown, MA

30+ days ago

Associate Director Regulatory Affairs, Oncology GSK plc

Waltham, MA

$138,750–$231,250 / 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. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.

30+ days ago

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

Cambridge, MA

$170,900–$231,300 / year

The Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data packages to the US FDA and other international health agencies (HA). Additional responsibilities include involvement in thewriting and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on regulatory requirements worldwide, and interpreting regulatory intelligence for the internal teams.

11 days ago

Director, Global Regulatory Affairs, Neuroscience 3316 Takeda Development Center Americas

Boston, Massachusetts

Demonstrates acceptable 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. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.

12 days ago

Senior Regulatory Affairs Specialist Boston Scientific Corp

Marlborough, MA

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.

30+ days ago

Senior Regulatory Affairs Specialist Meridian Bioscience Inc

North Billerica, MA

$101,600–$131,900 / year

Responsible for supporting regulatory activities regarding released product, including, MDR investigations submissions, post market risk assessments (HHA), supports maintenance of the product Technical File in support of CE Marking, and risk management file updates. Provides regulatory input and oversight to product lifecycle planning, including risk management activities, and monitors product lifecycle and compiles information associated with changes as directed.

6 days ago

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

Boston, MA

$218,058–$327,087 / year

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.

30+ days ago

Associate Director, Global Regulatory Affairs - GI & Inflammation 3316 Takeda Development Center Americas

Boston, Massachusetts

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. Acceptable and independent skills 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.

12 days ago

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Regulatory Affairs Jobs in Westwood, MA

Principal Customer Solutions Architect, Ads Regulatory Compliance Microsoft

Manager, Regional Regulatory Lead - LCM CSL

Director, Global Trade Waters Corporation

Sr. Network Architect ECLARO

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

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

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

Associate Director Regulatory Affairs Viridian Therapeutics Inc

Director of Regulatory Affairs, Post-Market Compliance Werfen

Manager, Regulatory Affairs Program Canadian Nuclear Laboratories Ltd

Assoc. Director, Regulatory Affairs Advertising and Promotion Definium Therapeutics Inc

Associate Director / Director, Regulatory Affairs Treeline Biosciences, Inc.

Associate Director / Director, Regulatory Affairs Treeline Biosciences Inc

Associate Director Regulatory Affairs, Oncology GSK plc

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

Director, Global Regulatory Affairs, Neuroscience 3316 Takeda Development Center Americas

Senior Regulatory Affairs Specialist Boston Scientific Corp

Senior Regulatory Affairs Specialist Meridian Bioscience Inc

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

Associate Director, Global Regulatory Affairs - GI & Inflammation 3316 Takeda Development Center Americas

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