Division Chief-Academic Specialists in General Obstetrics & Gynecology, UMass Memorial Medical Group UMass Memorial HealthDivision Chief-Academic Specialists in General Obstetrics & Gynecology, UMass Memorial Medical GroupWorcester, MAWhere relevant, oversee or collaborate with specialty sections such as Pediatric & Adolescent Gynecology, Complex Family Planning, and Complex Benign Gynecology/Minimally Invasive Gynecologic Surgery, and other subspecialty divisions including Maternal-Fetal Medicine, Gynecologic Oncology, Reproductive Endocrinology and Infertility, and Urogynecology. The largest division in the Department, including academic specialists in general obstetrics and gynecology, family planning specialists, complex benign gynecology/minimally invasive gynecologic surgery specialists, pediatric and adolescent gynecology specialists, and advanced practice clinicians.
Senior International Regulatory Affairs Specialist Butterfly NetworkSenior International Regulatory Affairs SpecialistBoston, MAThis 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.
Senior Regulatory Affairs Specialist Boston Scientific CorpSenior Regulatory Affairs SpecialistMarlborough, MAThe 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.
Senior International Regulatory Affairs Specialist Butterfly Network IncSenior International Regulatory Affairs SpecialistBurlington, MAThis 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.
NewRegulatory Affairs Specialist CareerscapeRegulatory Affairs SpecialistBoston, MA$90,000–$125,000 / yearFull timeOur 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.
Regulatory Affairs Specialist HP HoodRegulatory Affairs SpecialistWilmington, MassachusettsDocument maintenance & communication for support of claims, product and packaging regulatory compliance, customer requests utilizing Hood systems, posting and monitoring portal content, and providing support to operations and food safety & quality for document requests during third party and customer audits. Shared responsibilities include: technical label review and approval, updates/maintenance of systems housing product nutrition and finished product assets, and customer requests for technical information and regulatory documents.
Senior Regulatory Affairs Specialist Dentsply Sirona IncSenior Regulatory Affairs SpecialistWaltham, MAFor California Residents: We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistCambridge, MA$99,000–$157,000 / yearThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. • Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.
Regulatory Affairs Specialist Dentsply Sirona IncRegulatory Affairs SpecialistWaltham, MADentsply 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. Key Responsibilities: Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissions and technical files for CE Marking.
Principal Regulatory Affairs Specialist Medtronic PlcPrincipal Regulatory Affairs SpecialistBoston, MAThis role is responsible for shaping and executing global regulatory strategies, with a strong focus on pre-market submissions and early engagement with the global regulatory partners and/or regulatory authorities, as appropriate, across the United States, European Union, China, Japan, and Australia. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, China PTR submissions, and EU MDR Technical Documentation.
Regulatory Affairs Specialist HP Hood LLCRegulatory Affairs SpecialistWilmington, MADocument maintenance & communication for support of claims, product and packaging regulatory compliance, customer requests utilizing Hood systems, posting and monitoring portal content, and providing support to operations and food safety & quality for document requests during third party and customer audits. Education and Experience: A BA/BS degree in biology, chemistry, food science, food regulatory affairs, nutrition, packaging science, or related scientific field, 2-5 years of professional experience, preferably in regulatory in the food industry.
Senior Regulatory Affairs Specialist Wolters Kluwer N.V.Senior Regulatory Affairs SpecialistWaltham, MAAbout the Role: As the Senior Regulatory Affairs Specialist, you will serve as a regulatory lead expert supporting the expansion of our Software as a Medical Device (SaMD) portfolio across global markets. Serve as primary author and owner of major submissions, including 510(k), De Novo requests, CE Technical Documentation, UKCA dossiers, and global regulatory filings.
Senior Regulatory Affairs Specialist Smith & Nephew PlcSenior Regulatory Affairs SpecialistMansfield, MA$101,500–$152,250 / yearThe anticipated base compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate's qualifications, job-related knowledge/skills, geographical location. Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
Regulatory Affairs Specialist LGC LtdRegulatory Affairs SpecialistMilford, MAOur integrated portfolio of products, services and expertise supports our purpose of Science for a Safer World and we have embodied our mission by working with customers to enable research into life-altering treatment for disease and illness worldwide. LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, parental responsibilities, religion, or belief.
GSS Principal Regulatory Affairs Specialist, Intelligence & Strategy Hologic IncGSS Principal Regulatory Affairs Specialist, Intelligence & StrategyMarlborough, MAWhy join Hologic: You will have the opportunity to get in on the ground floor at a high growth world class manufacturing facility working on life-saving medical devices with potential for future growth. At Hologic, we are seeking a Quality Assurance Engineer - Product Quality to play a critical role in managing product holds .
Senior Regulatory Affairs Program Specialist Zoll Data Systems, Inc.Senior Regulatory Affairs Program SpecialistChelmsford, MARemoteThe Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Evaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle.
Senior Regulatory Affairs Program Specialist ZOLL MedicalSenior Regulatory Affairs Program SpecialistChelmsford, MassachusettsRemoteThe Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Essential FunctionsEvaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle.
Sr Regulatory Affairs Spec Medtronic PlcSr Regulatory Affairs SpecBoston, MAThis role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Sr. Regulatory Affairs Spclst RadNet IncSr. Regulatory Affairs SpclstSomerville, MAQualifications include: • Bachelor's degree in relevant field (or equivalent experience) • 8 - 12 years working in a regulated industry (FDA and Software as a Medical Device preferred) • Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. Regulatory Affairs Specialist, this position will: • Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.
Senior Manager, Regulatory Affairs NAM Straumann Holding AGSenior Manager, Regulatory Affairs NAMAndover, MAThis role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams. This role collaborates closely with global regulatory counterparts within the Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) and manages/develops regulatory staff and/or leads complex regulatory projects.
Principal Specialist - Regulatory Affairs & Compliance Gorton'sPrincipal Specialist - Regulatory Affairs & ComplianceGloucester, MassachusettsMonitor and evaluate emerging regulatory trends, enforcement actions, recalls, and global food safety risks to proactively manage regulatory risks and ensure company strategies remain aligned with current and future compliance requirements. - Provide technical expertise to support Gorton’s businesses in all areas related to ingredients, labeling and claims, legal, governmental and regulatory issues, including FDA registration requirements.
Regulatory Affairs Talent Pool (US & Canada) Parexel International CorpRegulatory Affairs Talent Pool (US & Canada)MARegulatory Affairs is a diverse and dynamic field, offering pathways for specialists across multiple disciplines: • Labeling Operations - ensuring accuracy and compliance in product information. Our Regulatory Affairs opportunities offer the ability to work remotely from home, empowering you to contribute globally while maintaining balance in your personal and professional life.
Contractor, Sr. Manager/AD, Regulatory Affairs StratAcuity Staffing Partners IncContractor, Sr. Manager/AD, Regulatory AffairsWaltham, MA$100–$126 / hourIn terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
Sr. Regulatory Affairs Spclst DeephealthSr. Regulatory Affairs SpclstSomerville, Massachusetts$120,000–$165,000 / yearRegulatory Affairs Specialist, this position will: · Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. · Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.
Head of Global Regulatory Affairs and Strategy Isomorphic Labs LimitedHead of Global Regulatory Affairs and StrategyCambridge, MABy harnessing AIs powerful capabilities, we can use it to model complex biological phenomena to help design novel molecules, anticipate how drugs will perform and develop innovative medicines to treat and cure some of the worlds most devastating diseases. The experienced and visionary Head of Global Regulatory Affairs and Strategy will lead regulatory strategy for all assets from IND to POC to registration and leverage AI to advance initiatives to transform regulatory pathways.
Senior Manager, Regulatory Affairs Hologic IncSenior Manager, Regulatory AffairsCambridge, MATechnical Documentation Specialist Role location: Cambridge, UK Discover a career with real meaning. Product DevelopmentEngineer Role location: Cambridge, UK Discover a career with real meaning.
Staff Regulatory Affairs Associate (Digital Health & AI Technologies) Whoop IncStaff Regulatory Affairs Associate (Digital Health & AI Technologies)Boston, MA$170,000–$220,000 / yearAt 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.
NewRegulatory Affairs Associate Ajinomoto Cambrooke, Inc.Regulatory Affairs AssociateAyer, MassachusettsThe 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. • Assist with RAM with investigating and resolving discrepancies related to packaging, labeling or documentation, and collaborating with internal teams to implement rapid, compliant solutions.
NewRegulatory Affairs Associate Ajinomoto Health & Nutrition North America, Inc.Regulatory Affairs AssociateAyer, MassachusettsThe 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. • Assist with RAM with investigating and resolving discrepancies related to packaging, labeling or documentation, and collaborating with internal teams to implement rapid, compliant solutions.
Associate Director Regulatory Affairs Viridian Therapeutics IncAssociate Director Regulatory AffairsWaltham, MAReporting 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.
Associate Director Regulatory Affairs CMC Alnylam Pharmaceuticals IncAssociate Director Regulatory Affairs CMCMA$170,900–$231,300 / yearLead 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.
Associate Director, Regulatory Affairs Rhythm Pharmaceuticals IncAssociate Director, Regulatory AffairsBoston, MA$160,000–$240,000 / yearFor 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.
Director, Global Labeling - Regulatory Affairs SpringWorks Therapeutics IncDirector, Global Labeling - Regulatory AffairsBillerica, MA$182,100–$273,100 / yearYour 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.
Associate Director, Regulatory Affairs Entrada Therapeutics IncAssociate Director, Regulatory AffairsBoston, MARemote$171,000–$204,000 / yearWe 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).
Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL) Intellia Therapeutics IncAssociate Director, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL)Cambridge, MARemote$193,176–$236,104 / yearThis 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.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyWaltham, MA$138,750–$231,250 / yearThis 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.
Director, Regulatory Affairs Nova BiomedicalDirector, Regulatory AffairsWaltham, MA$210,000–$270,000 / yearOversees 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. Own post-market regulatory obligations, including vigilance/adverse event reporting, Field Safety Corrective Actions/recalls (as applicable), regulatory reporting, and support for post-market performance follow-up and performance evaluation report updates under IVDR, as well as post-market surveillance and vigilance requirements under UK MDR 2002.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineBoston, MA$190,800–$300,300 / yearRequired 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.
Associate Director, Regulatory Affairs Rhythm PharmaceuticalsAssociate Director, Regulatory AffairsBoston, MAFull timeFor 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.
Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics IncSr. Manager/Associate Director, Regulatory AffairsWaltham, MA$161,000–$187,000 / yearOruka'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.
Sr. Manager/Associate Director, Regulatory Affairs Oruka TherapeuticsSr. Manager/Associate Director, Regulatory AffairsWaltham, CaliforniaOruka’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.
Associate Director, Regulatory Affairs Entrada TherapeuticsAssociate Director, Regulatory AffairsBoston, MassachusettsRemoteWe 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).
Associate Director, CMC Regulatory Affairs (Hematology/Oncology) Regeneron PharmaceuticalsAssociate Director, CMC Regulatory Affairs (Hematology/Oncology)Warren, MassachusettsRemotePerform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents; • Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks. • Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
Associate Director, Global Regulatory Affairs - GI & Inflammation TakedaAssociate Director, Global Regulatory Affairs - GI & InflammationBoston, MassachusettsDemonstrates 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.
Associate Director Regulatory Affairs – Vascular (on-site) AbbottAssociate Director Regulatory Affairs – Vascular (on-site)Westford, MassachusettsMaintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders. As a manager, the function of an Associate Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.
Policy Manager, Government and Regulatory Affairs Blue Cross and Blue Shield of Massachusetts IncPolicy Manager, Government and Regulatory AffairsBoston, MA$102,330–$125,070 / yearAn 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.
Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health TakedaAssociate Director, Global Regulatory Affairs, Precision Medicine & Digital HealthMassachusettsRemotePartner 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. Provides strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our products across therapeutic areas and to ensure goals/objectives are met.
Executive Director, Regulatory Affairs Merck & Co IncExecutive Director, Regulatory AffairsBoston, MA$255,800–$402,700 / year10% 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.
Senior Associate, Regulatory Affairs MapLight TherapeuticsSenior Associate, Regulatory AffairsBurlington, MassachusettsProvide and maintain IND/CTA documentation support in collaboration with Regulatory Lead (e.g., draft and prepare forms and cover letters, liaise with and transfer documents for submissions to/from the publishing vendor or CRO). We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.