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
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the CMC Documentation Manager - Regulatory Submissions Lead in New Brunswick, NJ vacancy
- Bristol Myers Squibb is seeking a Manager for CMC Documentation & Specifications in New Brunswick, NJ. This role entails authoring CMC regulatory submissions, collaborating closely with various departments to ensure timely filings. The ideal candidate will have a degree...SuggestedFlexible hours
$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... ...Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-...SuggestedHourly payContract workWork at officeLocal areaMonday to Friday- ...is seeking an Executive Director for Regulatory Affairs based in Rahway, NJ. This... ...involves overseeing the regulatory CMC team and ensuring successful development... ...candidate will be responsible for managing CMC submissions, leading cross-functional teams, and influencing...Suggested
- The Musculoskeletal Transplant Foundation in Edison, NJ, is seeking a Regulatory Affairs Manager to oversee regulatory submissions, inspections, and audits. This role includes managing the Regulatory Affairs team, budget, and compliance with U.S. and international regulations...Suggested
- ...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...Suggested
$99k - $125k
...leadership and operational management of the Regulatory Affairs function. This... ...activities, including regulatory submissions, inspections and audits,... ...review, quality system documentation, risk management, and design... ...,000/yr. Responsibilities Lead, coach, and develop...Temporary workWork experience placementMonday to FridayFlexible hoursMusculoskeletal Transplant Foundation
Edison, NJ1 day ago$190.8k - $300.3k
...Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5) Under... ...Scientist is responsible for the leading the preparation and submission of CMC sections for... ...CMC Regulatory Strategy Document for projects of increasing... ...to defined timelines. Manage execution of CMC documentation...Full timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$42.85 - $45.45 per hour
...Technical Writer and Document Specialist (TW/DS) will... ...Project and Portfolio Management Office (PMO). This... ...for delivering CMC documentation (dossier... ...documents) to support the regulatory strategy for a late-stage... ...on timelines for submissions. The position interfaces...Work at officeEclaro
New Brunswick, NJ4 days ago- MSD Malaysia is looking for a Director in Drug & Device Combos to lead regulatory CMC activities for autoinjectors and inhalation products. This role demands over 10 years of experience in pharmaceutical research or regulatory CMC. The ideal candidate will possess strong...Remote job
$137k - $140k
Amneal Pharmaceuticals LLC (J0P) is seeking a Manager for its QC Lab located in Piscataway, NJ. The successful candidate will oversee the quality control laboratory’s activities, ensuring timely delivery of materials and strict adherence to GMP compliance. The role requires...- ...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
TechDigital Group
New Brunswick, NJ16 hours ago - 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...
- Labcorp is seeking a dynamic Lab Supervisor for our Cytology department in Raritan, NJ. This leadership role focuses on supervising the cytology laboratory's screening area while ensuring compliance and quality control among the Cytotechnologists. Qualified candidates must...Relocation package
- ...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...
- ...Chemistry, Manufacturing, Control for Biologics (Biologics-CMC) is accountable for managing a team of CMC professionals and ensuring rigor in CMC regulatory strategy as well as delivery of high quality CMC submissions for late phase new modality biologics products. -The...
Merck & Co. Inc
Rahway, NJ4 days ago - 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
- A leading engineering consulting firm is seeking a Senior Water Resources... ...studies, and stormwater management design Prepare technical reports and supporting documentation for NJDOT, NJDEP, NYSDOT, and related agency submissions Support flood hazard area and permitting...Work at officeWork from homeFlexible hours
$124k - $174k
...Career Opportunities: Regulatory Affairs Project Manager (173814) Requisition ID 173... ...Project Manager, you will lead the planning, execution,... ...complex global regulatory submissions and ensure the rigorous maintenance... ..." sessions and updates documentation standards (SOPs and WIs)...Hourly payLocal areaRelocationColgate-Palmolive
Piscataway, NJ3 days ago- Merck & Co. is seeking a skilled Biostatistical Scientist to provide leadership in drug development projects in Rahway, New Jersey. The role requires proficiency in statistical methodologies and tools to support the research and development of medical drugs and vaccines...
- Atrium Staffing is seeking a Payroll Manager based in Woodbridge Township, New Jersey. This standalone role is critical for accurate payroll processing across various regions in the US. The successful candidate will manage end-to-end payroll processing and ensure compliance...
- Responsibilities Lead and manage publishing activities for IND, NDA, ANDA, Amendments... ...Safety Reports, and Promotional Submissions. Oversee submission-level and document-level publishing including... ...control checks to ensure error-free regulatory submissions. Manage workload...
$255.8k - $402.7k
...Executive Director, Regulatory AffairsApplyremote... ...Biologics (Biologics-CMC) is accountable for managing a team of CMC... ...of high quality CMC submissions for late phase new... ...Leadership Team. This lead plays a critical role... ...major submission documents and response to Health...For contractorsLocal areaRelocationVisa sponsorshipFlexible hours$25 - $50 per hour
...Role Overview TSA is accepting applications for Lead and Supervisory Transportation Security Officers at airports in Edison. These... ...teams Ensure TSA compliance Train and mentor officers Manage checkpoint operations Disclaimer This is not a direct job...Shift workNight shiftWeekend work- ...leadership and scientific team members, including calendar management, meeting scheduling, and travel coordination as... ...meeting materials, presentations, and internal documentation. Support the preparation and submission of expense reports when required. Support the coordination...Full timeWork at office
$75k - $85k
Diesel Direct, Inc. is seeking a Human Resources Manager for their North Brunswick Township, NJ office. This full-time, in-person role involves recruiting, training, and managing HR programs while ensuring compliance with employment laws. The ideal candidate will have 3...Full timeWork at office$137k - $235.75k
...Labeling Product Leader (Regulatory Affairs) Location:... ...with Global Regulatory Leads and functional partners... ...and primary labeling documents (Company Core Data Sheet... ...Entity (NME) submissions preferred. Relevant experience... ...working with document management systems. Ability to...Temporary workWork experience placementLocal areaWorldwide$21.27 - $27.18 per hour
...the Jobs Hub app or search for Browse Jobs. The role of the Shift Lead is to perform the duties of a Client Services Coordinator or Vet Assistant when not filling in or assisting the Practice Manager or Chief of Staff in guiding the team to maximize productivity and...Hourly payMinimum wageFull timeTemporary workPart timeLocal areaFlexible hoursShift workWeekend workAfternoon shiftBanfield
Metuchen, NJ5 days ago- ...culture built on five core values: Generosity First, Always: We lead with kindness. Our best work happens when we act in service of... ...performance success in partnership with our Assistant General Managers and General Managers by leading the team daily, promoting a...Local areaShift work
CAVA
North Brunswick, NJ6 days ago $16.75 - $23 per hour
...This position serves as the field team lead and provides functional direction to field... ...with customers and business partners to manage difficult customer situations, including... ...and could be subject to variation based on regulatory minimum wage requirements. Actual pay rates...Hourly payMinimum wageWork at officeLocal areaShift workNight shiftPetco
South River, NJ2 days ago- ...Description Opens and closes the store in the absence of store management, including all required systems start-ups, required cash... ...additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within the required...Work experience placementSeasonal workLocal areaShift work
Walgreens Boots Alliance
Franklin, Somerset County, NJ3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CMC Documentation Manager - Regulatory Submissions Lead. Be the first to apply!
Related searches
- regulatory contract New Brunswick, NJ
- food regulatory New Brunswick, NJ
- regulatory scientist New Brunswick, NJ
- regulatory law New Brunswick, NJ
- regulatory engineer New Brunswick, NJ
- regulatory New Brunswick, NJ
- clinical documentation manager
- technical writer documentation manager
- payroll compliance manager
- engineering compliance manager