Regulatory CMC Lead, Sterile Injectables & Generics
Breckenridge Pharmaceutical
Breckenridge Pharmaceutical is seeking a Regulatory Affairs Manager to support regulatory CMC strategies and submissions for generic products, including complex sterile injectables and drug-device combinations. You will prepare, review, and submit filings throughout the product lifecycle while ensuring FDA compliance and eCTD standards. Reporting to the Director of Regulatory Affairs, you will lead regulatory activities for assigned programs, collaborate with R&D, Analytical Development, #J-18808-Ljbffr Breckenridge Pharmaceutical
- Job Description The Sterile Product Development group... ...including long‑acting injectables (LAIs), across small molecules... ...dosage forms Lead LAI formulation and delivery... ...Non‑Clinical, Quality, Regulatory, Manufacturing, and... ...mitigation, and contribute to CMC regulatory submissions...RegulatoryFor contractors
- Katalyst CRO in Madison, New Jersey, is seeking a regulatory affairs expert to act as the US Agent for all products. This role involves communication with the FDA, managing the CMC team, and ensuring compliance with drug registration processes. The ideal candidate will...Regulatory
- ...Bristol-Myers Squibb is looking for a Senior Manager, Sterility Assurance in Summit, NJ. This pivotal role will manage the Sterility... ...Assurance for our CAR T manufacturing site, ensuring compliance with regulatory standards while overseeing aseptic process validation and...RegulatoryFlexible hours
$173.2k - $272.6k
...integrated stage‑appropriate CMC development and commercialization... ...long‑term supply. Lead DCT—critically assess all team... ...impact technical, operational & regulatory success or timelines. Analyze... ...Improvements, Results‑Oriented, Sterile Filling, Strategic Thinking, Writing...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- BioSpace is hiring a GRA CMC Lead in Morristown, NJ. In this role, you will manage CMC regulatory strategies and work closely with health authorities, ensuring compliance and effective communication. The ideal candidate will have a relevant BS/BA degree, at least 4 years...Regulatory
- Eacademy Sanofi in Morristown, NJ is seeking a GRA CMC Lead to manage regulatory strategies for the R&D team. This role involves direct interaction with Health Authorities and collaboration on CMC activities. The ideal candidate will have a BS/BA in a scientific field,...Regulatory
- ...excellent communication skills, and the ability to thrive in a fast-paced setting. Join a dynamic team that values innovation and quality, and contribute to impactful projects that enhance operational efficiency and regulatory compliance. #J-18808-Ljbffr TechDigital GroupRegulatoryContract work
$142.4k - $224.1k
...Rahway, New Jersey, is seeking a skilled professional to lead the Mixed Modalities team in sterile product development for biologics. The role involves... ..., interfacing with stakeholders, and ensuring regulatory compliance. The ideal candidate has a Ph.D. in relevant...Regulatory- About The Job As GRA CMC Lead within our R&D team, you will be responsible for managing a portfolio of projects and/or marketed products... ...The GRA CMC Lead, Vaccines is responsible for the global CMC regulatory strategy definition, managing variation approvals and...RegulatoryLocal area
$145k - $165k
...value and cost-effective generic drugs in the United... .... About the Role The Regulatory Affairs Manager is responsible... ...of regulatory CMC strategies and submissions... ..., including complex sterile injectables and drug-device... ...as the Regulatory CMC lead for assigned development...RegulatoryFlexible hours- Bristol-Myers Squibb is seeking a Director, Regulatory CMC for Cell Therapy in Madison, NJ. In this pivotal role, you will oversee multiple development and lifecycle management projects, ensuring regulatory compliance and strategic direction in alignment with global guidelines...Regulatory
$173.2k - $272.6k
...integrated stage-appropriate CMC development and commercialization... ...long-term supply Lead DCT.- Critically assesses all... ...impact technical, operational & regulatory success or timelines. -Analyzes... ...Improvements, Results-Oriented, Sterile Filling, Strategic Thinking, Writing...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...Job Description The Sterile Product Development group... ...including long-acting injectables (LAIs), across small... ...parenteral dosage forms Lead LAI formulation and... ...Non-Clinical, Quality, Regulatory, Manufacturing, and Engineering... ...Contribute to CMC regulatory submissions...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$121.07k - $146.7k
VetJobs and Military Spouse Jobs is seeking a Sr. Manager, Sterility Assurance in Summit, NJ. You will manage critical processes supporting CAR T manufacturing and ensure compliance with regulatory standards. Ideal candidates should possess advanced knowledge of cGMP's...Regulatory$130k - $200k
A leading biotechnology company is seeking a Director of Regulatory Affairs for Infectious Diseases. This position is responsible for overseeing global regulatory strategies, submissions, and cross-functional leadership. The ideal candidate will possess a strong scientific...RegulatoryRemote job- ...Technical Writer and Document Specialist in Summit, NJ, to support regulatory strategy for Cell Therapy clinical portfolios. This role... ...effective collaboration across technical functions and management of CMC documentation for submissions. Successful candidates will...Regulatory
- ...label management within the S12 Cell Therapy manufacturing facility. In this pivotal role, you will lead the Label Operations team, ensuring compliance with regulatory standards and efficient label issuance processes. The ideal candidate should have a B.S. Degree with...Regulatory
- Sanofi in Morristown, NJ seeks a Platform Lead for Regulatory Strategy and Continuous Improvement, coordinating cross-functional programs across global regulatory landscapes in CMC and device areas. You will establish global responsibilities, build governance structures...Regulatory
- Sanofi Morristown seeks a Regulatory Strategy & Continuous Improvement - Platform Lead to steer global CMC/Device regulatory activities. You will lead multiple cross-functional programs, align project objectives with strategy, and drive change management across interconnected...Regulatory
$18 - $21 per hour
...displayed at the store to support accurate pricing of products. Ensures any additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within the required time frame. Assist with bookkeeping activities, including...RegulatoryHourly payWork experience placementSeasonal workLocal areaShift work- EmergencyMD is seeking a regulatory CMC specialist to provide global regulatory support throughout the product lifecycle in Morristown, New Jersey. The role involves managing high-quality CMC regulatory submissions and ensuring timely execution of corporate goals. The...Regulatory
- HUTCHMED seeks a Regulatory Affairs CMC Director to lead the regulatory team and develop global CMC strategies to support biologics and chemical drug approvals in the US, EU, and internationally. The ideal candidate will have extensive experience in the pharmaceutical industry...Regulatory
- ...seeking the Executive Director, Chemistry, Manufacturing, and Controls for Biologics (Biologics-CMC) who will lead a team of CMC professionals and ensure rigorous regulatory strategy and high-quality CMC submissions for late-stage biologics programs. As a senior member...RegulatoryWorldwide
- ...of direct reports, ensuring regulatory compliance, medication safety... ...regular audits and inspections of sterile compounding practices.... ...New Jersey, we are one of the leading non-profit health care systems... ...errors, accidents, injuries and injections, as well as systems hospitals...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsFor subcontractorLocal areaFlexible hoursShift workAfternoon shift
$199.95k - $242.3k
Bristol Myers Squibb is seeking a Director, Regulatory CMC to oversee multiple development projects and represent the organization on cross-functional teams. This role is essential in ensuring compliance with global regulatory guidelines and managing the growth of direct...Regulatory- Bristol Myers Squibb EU Policy is seeking a Director for Regulatory CMC in Cell Therapy. In this role, you will oversee management of multiple development projects, represent GRS-CMC in cross-functional teams, and ensure compliance with regulatory requirements. The ideal...Regulatory
- About the Role We’re seeking a Fraud & AML Functional Lead to drive the global deployment of next-generation Anti-Money Laundering... ...US, EMEA, and APAC regions. You’ll work at the intersection of regulatory compliance, fraud prevention, and go-to-market execution , ensuring...RegulatoryFull timeWorldwide
- ...The role requires familiarity/knowledge with the use of all sterilization and/or HLD equipment at assigned practices and maintains Instructions... ...ensuring AMG practices follow professional, safety and regulatory requirements and standards. Familiar with and assists in...RegulatoryFull timeTemporary workPart timeFor contractorsFor subcontractorFlexible hours
$148.5k - $214.5k
Job Title: Regulatory Strategy & Continuous Improvement - Platform Lead Location: Morristown, NJ Overview As the Platform Lead within our R&D team, you will spearhead... ...will establish global responsibilities across GRA CMC and GRA Device departments, build cross‑functional...RegulatoryWorldwide- ...automation engineer to maintain validated automation systems and support sterile clinical manufacturing. You will lead changes, CAPAs, and collaborate across teams to ensure data integrity and regulatory compliance. The role involves on-floor troubleshooting,...Regulatory
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