Associate Director Regulatory Affairs
Anagram Therapeutics, Inc.
Anagram Therapeutics, Inc. in Natick, MA is seeking an experienced Associate Director to lead Regulatory Affairs CMC across development and lifecycle stages.
You will plan submission strategies, prepare CMC documents for INDs/NDAs/BLAs, and collaborate with cross-functional teams to ensure compliant, timely filings while navigating evolving regulatory requirements.
Lead regulatory strategy, guide teams through Module 3, and drive inspections readiness in a fast-paced biotech setting.
#J-18808-Ljbffr- Responsibilities: The Associate Director, Regulatory Affairs CMC will be responsible for leading regulatory CMC activities for Anagram’s portfolio of products, through all stages. Assist with developing Regulatory-CMC strategies and collaborating with key stakeholders...Suggested
$154.4k - $242.55k
...global strategies to maximize global regulatory success towards achievement of program... ...regional counterparts.Accountabilities:The Associate Director will be responsible for complex or... ...understanding broad concepts within regulatory affairs and implications across the...SuggestedMinimum wageTemporary workLocal areaRemote work$154.4k - $242.55k
...boundaries of what is possible in order to bring life-changing therapies to patients worldwide.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...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$138.75k - $231.25k
Associate Director Regulatory Affairs, OncologyAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent...SuggestedFull timeLocal area$181k - $208k
...Associate Director, Regulatory CMC (Biologics) Location: Hybrid – Waltham, MA (Candidates will be required to be in-office 3 days/week) About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic...SuggestedWork at office3 days per week$175.35k - $219.2k
...About the Job: The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities...- ...of differentiated investigational therapeutic candidates for well-validated targets. 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...Temporary workWork at officeLocal areaImmediate start3 days per week
- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: R-100086**Job Description:****Company Overview**Founded over a decade ago, CRISPR Therapeutics is a leading...Contract workRemote work
- ...Job Description Job Description Associate Director, Regulatory Affairs Location: Boston, MA (Hybrid or East Coast, USA) Employment Type: Full-time, Permanent About the Company Our client is a growing consultancy supporting innovative biotechnology and pharmaceutical...Permanent employmentFull time
- ...pipeline of differentiated investigational therapeutic candidates for well-validated targets. 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...Work at office3 days per week
- Associate Director, Global Regulatory Affairs - Marketed Products Boston, Massachusetts | Hybrid Working Are you an experienced Regulatory Affairs professional looking to influence global regulatory strategy for innovative therapies that improve patients' lives around...Worldwide
- About The Role We are seeking a highly skilled and experienced Associate Director / Director of Regulatory Affairs to join our growing clinical team. This hands-on position will be responsible for overseeing and managing global regulatory activities to ensure compliance...
$190k - $210k
...making a profound impact, together - forour patients, for your career, and for what’s beyond . About the Role Associate Director, Global Regulatory Affairs, Compliance As the Global Associate Director, Regulatory Affairs Compliance, reporting to the Senior Director,...Work at officeFlexible hours2 days per week$155k - $190k
...individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do The Associate Director, Global Regulatory Affairs will be responsible for day-to-day regulatory activities of early/late phase investigational products, leading...Full timeLocal areaFlexible hours3 days per week- Position: Associate Director, Regulatory Affairs - Advertising/Promotion Location: Boston, MA Job Id: 112983 # of Openings: 1 MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient...Hourly payFor contractorsWork at office
- Alexion Pharmaceuticals, Inc. is seeking an Associate Director of Advertising and Promotion Compliance in the... .... The role involves reviewing and approving regulatory content for promotion, disease awareness, and public affairs communications, and partnering with teams on...
- Associate Director / Director, Regulatory Affairs Watertown, Massachusetts, United States Associate Director / Director, Regulatory Affairs About the Role We are seeking a highly skilled and experienced Associate Director / Director of Regulatory Affairs to join our growing...
$168k - $252k
Job DescriptionGeneral Summary:The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory... ...role requires advanced understanding of regulatory affairs frameworks in the US, Europe, or other international...Full timeSummer workRemote workFlexible hours2 days per week$70k - $150k
...Associate Manager, Financial Investigations Kroll's North American Investigations, Diligence and Compliance - Specialist practice... ...a broad range of complex investigations, forensic accounting, regulatory compliance, internal (client) investigations, insider risk compliance...Temporary workInterim roleFlexible hours- Moderna, in the United States, seeks an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC activities across product lifecycles, develop global strategies, and guide product teams toward compliant submissions. You will lead interactions with health authorities...
- Vertex Pharmaceuticals Incorporated is seeking an Associate Director of Chemistry Manufacturing Controls (CMC) to lead global regulatory strategies for biologics. You will author, review, and deliver high-quality regulatory submissions and serve as the primary CMC interface...
$133.04k - $199.56k
...Job Title: Clinical Regulatory Writer, Associate Director / Manager Location: Boston, MA OR Gaithesrburg, MD- Hybrid (3 days onsite) Introduction to role: Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director...Hourly payTemporary workWork at officeFlexible hours3 days per week- ...strongly preferred 10+ years of professional experience in legal, regulatory, compliance environments; attorneys with “Big Law” and/or in... ...your family.WHAT YOU'LL DOAs the Ethics & Compliance (E&C) Associate Director of Investigations, you will lead in driving and shaping the...Apprenticeship
$166.4k - $249.6k
...Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial... ...degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field (advanced degree...Full timeSummer workRemote workFlexible hours2 days per week$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing...Permanent employmentFull timeWork at officeWork from home- AstraZeneca is seeking an Associate Director / Manager Clinical Regulatory Writer in Boston, MA or Gaithersburg, MD (hybrid, 3 days onsite). You will lead complex clinical-regulatory writing across a portfolio, ensuring regulatory and quality standards and shaping the...
- ...Inc.Posted: 2026-08-03Rhythm Pharmaceuticals Inc. in Boston is seeking an experienced Associate Director of Medical Writing to independently author and oversee clinical, regulatory, medical, and safety documents across the development lifecycle.You will partner with cross...
$90k - $200k
...a broad range of complex investigations, forensic accounting, regulatory compliance, including business intelligence, internal (client)... ...Kroll's expert resources. Oversee and review the quality of Associates, Associate Managers, and Managers research and analysis on the...Temporary workFlexible hours- Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness... ...and governance forumsKnowledge and Skills:Knowledge of regulatory requirements and inspection expectations globallyExperience...Full timeSummer workRemote workFlexible hours2 days per week
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta... ...for product maintenance and compliance activities associated with marketed brands, ensuring continued benefit to patients...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week
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