CMC Documentation Manager - Regulatory Submissions Lead
Bristol-Myers Squibb
Bristol-Myers Squibb is seeking a Manager for CMC Documentation in New Brunswick, NJ. The role involves compiling and authoring CMC sections of regulatory submissions, coordinating with various teams to ensure timely document delivery. Ideal candidates will have a degree in organic chemistry or related fields along with at least 5 years of experience in pharmaceutical development. Strong communication skills and familiarity with document preparation tools are essential. This position offers competitive compensation and a variety of benefits to support a flexible work-life balance. #J-18808-Ljbffr Bristol-Myers Squibb
$204k - $244k
Scorpion Therapeutics is seeking a Director, Regulatory Affairs - CMC in Cranbury Township, New Jersey. This role involves... ...-CMC strategies for gene therapy products, leading the preparation and review of submission documents, and interacting with health authorities. The...Suggested$33.03 - $41.95 per hour
...GxP Services seeking a Technical Writer and Document Specialist to support CMC documentation for a late-stage clinical cell... ...Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional...SuggestedHourly payContract workWork at officeLocal areaMonday to Friday- ...Technical Writer and Document Specialist (TW/DS) will... ...Project and Portfolio Management Office (PMO). This individual... ...for delivering CMC documentation (dossier... ...documents) to support the regulatory strategy for a late-... ...on timelines for submissions. The position interfaces...SuggestedWork at officeLocal area
- ...CMC Dossier Sciences Team Member The CMC Dossier Sciences... ...and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement of... ...we prepare CMC regulatory documents Lead, coordinate, and manage CMC dossier preparation and...Suggested
$204k - $244k
Director, Regulatory Affairs - CMC (Chemistry, Manufacturing, and Controls) Responsibilities... ...development to licensure. Lead the preparation/review of CMC submission documents, registration dossiers, and... ...Global Project Team, Change Management team, and governance meetings...SuggestedTemporary work- ...Therapeutics is seeking an Associate Principal Scientist in Rahway, New Jersey, to drive CMC regulatory strategies for biologics. You will oversee authoring INDs, BLAs, and manage regulatory submissions, ensuring compliance with guidelines. The ideal candidate has over 10 years of...
- ...in Edison, NJ is seeking a qualified individual to lead publishing activities for regulatory submissions. The ideal candidate has a Bachelor’s or Master’s degree... ...in eCTD/NeeS publishing. Responsibilities include managing submissions, ensuring quality control, mentoring...
$189k - $325.45k
...Director, Global Regulatory Leader Johnson... ...regulatory requirements, CMC considerations,... ...related teams. Lead the project Global... ...health authority documents (e.g., IND/CTA,... ...critical review of submission documents to ensure... ...Negotiate and manage regional post-approval...Temporary workLocal areaRemote work$200k - $245k
Initial Therapeutics, Inc. is searching for a Regulatory Affairs Director in South Brunswick, NJ. This role demands a hands-on professional to manage NDA submissions and cross-functional execution for a late-stage biotech program. The successful candidate will have a Bachelor...- ...Senior Director, Regulatory Affairs Date: May 23, 2... ...direction and providing management support for the US... ...reviewing ANDAs pre- or post-submission, proactively working... ...(all critical) of documents for submission to US regulatory... ...experience required (CMC and PK/PD Clinical...
$165k - $220k
...NYSE/TSX: BLCO) is a leading global eye health company... .... The Director, Regulatory Affairs leads global... ..., Nonclinical, CMC, Quality, Safety, and... ..., ensure highquality submissions, and manage regulatory risk across... ...attention to detail and document accuracy. Demonstrated...Temporary workWork visa$336.9k
...Novo Nordisk is looking for a Head of Regulatory Affairs based in Plainsboro Township, NJ. The ideal candidate will define and lead the strategic agenda for the Regulatory Affairs team, managing U.S. product submissions and approvals while building relationships with the...Flexible hours- ...Merck & Co. is seeking a Head of Regulatory Affairs in Plainsboro Township, NJ. This role involves defining and leading regulatory strategy for product submissions and approvals, and engaging with the U.S. FDA to ensure compliance. Candidates must have a doctorate or...
$122k - $212.75k
...Technology Product & Platform Management Job Sub Function: Technical... ...for a(n) Sr. Manager, Regulatory Affairs. Johnson & Johnson announced... .... Job Overview This role leads the technology product strategy... ...that enable faster submissions, stronger compliance, and improved...Contract workLocal areaImmediate start- ...Entity is seeking a Director, Technology Product Group Leader for Submission Excellence. This role involves overseeing the development,... ...engineering, and global operationalization of solutions to accelerate regulatory submissions. The ideal candidate will have extensive...
$117k - $201.25k
Johnson & Johnson Innovative Medicine is seeking a CAPA Manager to oversee the Corrective Action Preventive Action (CAPA) process. Situated in New Brunswick, NJ, this role involves a significant focus on compliance within clinical research and quality assurance. The ideal...Remote job$40 - $42 per hour
...Technical Writer and Document Specialist (TW/DS) will... ...Project and Portfolio Management Office (PMO). This individual... ...for delivering CMC documentation (dossier... ...documents) to support the regulatory strategy for a late-... ...on timelines for submissions. The position interfaces...Hourly payWork at officeLocal area- ...Principal Scientist, Regulatory CMC - Biologics (R4) Responsibilities... ...to prioritize submissions. Complete detailed... ...post-approval change documentation. Plan, track, and... ...continued product supply. Lead authoring of clear,... ...leadership, project management, communication, interpersonal...
- A leading tech firm is seeking a Product Manager with extensive experience in regulatory submission processes and health authority queries. The role requires strong customer-facing skills and a deep understanding of pharma regulatory processes. Candidates with over 10 years...
- Associate Principal Scientist (Assoc. Director), Regulatory Affairs - CMC Company: Merck & Co. Location: Rahway, NJ. Job Description: Global Regulatory Affairs & Clinical Safety (GRACS) CMC - Associate Principal Scientist, CMC - Pharm Pre-approval (Respiratory/Inhalation...
- A leading global professional services firm is seeking a Tax Manager in New Brunswick to shape tax strategies and lead teams in delivering quality solutions. You will manage compliance, optimize tax processes, and identify opportunities for growth. The ideal candidate...
- ...LIQUENT Insight publisher or other electronic publishing systems, as well as knowledge of software development life cycle and regulatory submissions. The ideal candidate will be familiar with ICH Guidelines, GCP, and various Life Sciences regulations. This role emphasizes...
$336.9k
...Novo Nordisk in Plainsboro Township, NJ, is searching for a Head of Regulatory Affairs to lead and define the strategic agenda for the Regulatory Affairs team. The role entails managing product submissions and approvals, engaging with the FDA, and developing innovative...$21 per hour
..., you will play a key role in designing, managing, and optimizing solutions that keep goods moving efficiently. Whether you’re leading a team, engineering processes, or driving... ...from submitting unsolicited profiles. Any submissions of candidates without prior signed...Hourly payContract workSeasonal workLocal areaMonday to FridayNight shift- Regulatory Operations/Affairs Manager Onsite role New Brunswick, NJ Work Schedule: Mon -... ...provide relevant regulatory documentation (e.g. SOPs, Technical... ...transfer plans, and regulatory submission plans. Maintains strong... ...global personnel such as CMC. Participating in other...Contract workLocal areaWorldwide
- ...role is to execute OTC regulatory activities for new... ...timely approvals for US submissions and OTC Monograph product... ...strategies and documents for new product launches... ...support as appropriate • Manage compliance within... ...challenges, including leading implementation of improvement...Local area
$200k - $245k
...Pharma, Inc. ( is a leading privately‑owned US biopharmaceutical... ...for an experienced Regulatory Affairs Director to... ...for day‑to‑day NDA submission management and delivery. You... ...) including briefing documents, questions, response... ...across Clinical, CMC, Nonclinical, Biostatistics...Full timeWork at officeShift work- ...Biotech is seeking a Program Lead, Cell and Gene Therapy as... ...to senior leadership, and manage the commercial... ...ensuring technical excellence, regulatory readiness, operational execution... ...expectations. Support CMC submissions, PPQ documentation, change controls, and validation...Permanent employmentFull timeFor contractorsLocal area
- Global Viral Vector MSAT Lead - Global Manufacturing & Supply... ...Role Overview The Senior Manager, MSAT - Viral Vector Lead for... ..., Manufacturing, Quality, Regulatory, and Supply Chain teams to... ...Provide MSAT technical input to CMC regulatory submissions, health authority...Permanent employmentFull timeFor contractorsLocal area
- IEEE is looking for a Project/Program Manager to support educational programs for the Electronics Packaging Society (EPS). The incumbent... ...activities of the EPS Undergraduate Hands-On program, track submissions, and oversee financial processing in compliance with...
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