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Inspection Jobs in Melrose, MA

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Associate Director, Global Regulatory Affairs CMC 3316 Takeda Development Center Americas

Boston, Massachusetts

$154,400–$242,550 / 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 team’s 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.

30+ days ago

Associate Director, Regulatory Affairs Parabilis Medicines

Cambridge, MA

$170,000–$195,000 / year

We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options. Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable.

30+ days ago

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals

Woburn, MA

Brief team/department description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.

30+ days ago

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals Inc

Woburn, MA

30+ days ago

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals - US

Woburn, MA

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.

30+ days ago

Senior Director, Regulatory Affairs CMC – Small Molecule Beeline Medicines

Cambridge, Massachusetts

$242,000–$313,500 / year

Act as a fully integrated partner within the CMC team, attending key technical meetings, engaging daily with Process Development, Analytical, Manufacturing Sciences, Drug Supply and Quality colleagues, and translating regulatory strategy into practical guidance that enables the CMC team to make informed decisions and move programs forward with regulatory confidence. Demonstrate entrepreneurial drive and resourcefulness in executing CMC regulatory responsibilities — proactively seek out information, build relationships across the CMC organization, and find creative avenues to get things done; a successful CMC regulatory lead takes ownership of being plugged in, earns trust within the team, and removes barriers through initiative and ownership.

12 days ago

Associate Director, Regulatory Affairs, CMC- Biologics Alnylam Pharmaceuticals Inc

Cambridge, MA

$170,900–$231,300 / 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.

28 days ago

Associate Director, Regulatory Affairs, Cmc- Biologics Alnylam Pharmaceuticals, Inc.

Cambridge, MA

30+ days ago

Digital Health Regulatory Affairs Manager Johnson & Johnson

Danvers, MA

Remote

$117,000–$201,250 / year

Your core focus will be regulatory leadership for Digital Health across Heart Recovery's cardio-pulmonary product portfolio: the Impella Ecosystem (Heart Pumps), PreCardia (cardio-renal unloading - decompensated heart failure (ADHF), restoring kidney function) and Breethe (ECMO: respiratory failure) with particular emphasis on: Cybersecurity. Required Skills: Preferred Skills: Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility.

22 days ago

Senior Regulatory Affairs Specialist - Software OrganOx

Boston, MA

$115,000–$140,000 / year
Quick Apply

Under direction from the Director, Regulatory Affairs, Software and Innovation, the Senior Regulatory Affairs Specialist will be responsible for: · Providing regulatory affairs support for projects related to Digital Health, Software, Cybersecurity, Electromechanical devices and Regulatory Intelligence. Founded in 1921, Terumo Corporation strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

30+ days ago

Senior Manager, Regulatory Affairs, Advertising and Promotion Les Laboratoires Servier SAS

Boston, MA

$150,000–$170,000 / year

The Senior Manager, Regulatory Affairs Advertising and Promotion at Servier Pharmaceuticals will report to the Director of US Regulatory Affairs and Quality Management and is responsible for leading the day-to-day regulatory review of advertising, promotional, and educational materials. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision.

30+ days ago

Part Time Lecturer - Regulatory Affairs (Boston) Northeastern University

Boston, MA

Northeastern University's College of Professional Studies is seeking part-time faculty to teach graduate-level, on-ground courses in Boston for the Master of Science in Regulatory Affairs program and its associated graduate certificates. Instructional areas include, but are not limited to, drug and biologics development, medical device regulations, clinical trial management, commercialization of medical products/technology, law and intellectual property, international regulatory affairs, and regulatory writing.

20 days ago

Senior Manager Global Regulatory Affairs CMC CSL Behring LLC

Waltham, MA

Products is responsible for: Partnering closely with CSL's R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio. Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.

7 days ago

USA - Associate Director Global Regulatory Affairs (CMC) Mindlance

Cambridge, MA

Remote

Quick Apply

Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal PSPV stakeholders. Represents the pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required.

29 days ago

VP, Regulatory Affairs Prime Medicine, Inc.

Cambridge, MA

$313,000–$348,000 / year

Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies.

19 days ago

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Waltham, MA

$116,000–$160,000 / year

ROMVIMZA (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. In addition to advancing multiple product candidates from Deciphera's platform in clinical studies, QINLOCK (ripretinib) is Deciphera's switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

30+ days ago

Manager, Regulatory Affairs Deciphera

Waltham, MA

$116,000–$160,000 / year

30+ days ago

Associate Director, Regulatory Affairs - Advertising/Promotion (REMOTE) MannKind Corp

Boston, MA

Remote

Additional key job duties and responsibilities are as detailed below and will include: Providing strategic advice on advertising and promotional activities for assigned products in accordance with business goals and objectives, Maintaining current knowledge and understanding of FDA regulations/guidelines PhRMA guidelines and company policy and sharing new developments with impacted team members, Informs teams for assigned products and projects on implementation of compliant product labeling and communications. Job Summary: The Associate Director, Regulatory Affairs will be responsible for coordinating and completing regulatory review and approval of all commercial materials, representing the Regulatory team on both the Medical Review Committee (MRC) and Promotional Review Committee (PRC), and leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products.

30+ days ago

Sr. Regulatory Affairs Specialist Glaukos Corp

Burlington, MA

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

30+ days ago

Consultant II, Regulatory Affairs Advertising and Promotion Syner-G

Boston, MA

Remote

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. The Consultant II serves as a key regulatory partner to Commercial, Medical, Legal, and Global Regulatory teams, enabling timely and compliant execution of brand strategy across product launch and lifecycle activities.

30+ days ago

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Inspection Jobs in Melrose, MA

Associate Director, Global Regulatory Affairs CMC 3316 Takeda Development Center Americas

Associate Director, Regulatory Affairs Parabilis Medicines

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals Inc

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals - US

Senior Director, Regulatory Affairs CMC – Small Molecule Beeline Medicines

Associate Director, Regulatory Affairs, CMC- Biologics Alnylam Pharmaceuticals Inc

Associate Director, Regulatory Affairs, Cmc- Biologics Alnylam Pharmaceuticals, Inc.

Digital Health Regulatory Affairs Manager Johnson & Johnson

Senior Regulatory Affairs Specialist - Software OrganOx

Senior Manager, Regulatory Affairs, Advertising and Promotion Les Laboratoires Servier SAS

Part Time Lecturer - Regulatory Affairs (Boston) Northeastern University

Senior Manager Global Regulatory Affairs CMC CSL Behring LLC

USA - Associate Director Global Regulatory Affairs (CMC) Mindlance

VP, Regulatory Affairs Prime Medicine, Inc.

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Manager, Regulatory Affairs Deciphera

Associate Director, Regulatory Affairs - Advertising/Promotion (REMOTE) MannKind Corp

Sr. Regulatory Affairs Specialist Glaukos Corp

Consultant II, Regulatory Affairs Advertising and Promotion Syner-G

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