Global CMC Regulatory Lead for Biologics (Hybrid)
Johnson & Johnson Innovative Medicine
Scorpion Therapeutics is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities to guide regulatory strategies across development. You will integrate disease biology, pharmacology, and clinical data to shape scientific strategy and global CMC approaches. You will lead cross‑functional regulatory activities, prepare submissions, and ensure compliance with health authority standards while supporting lifecycle management and inspections. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine
- Merck & Co., Inc. is seeking a Senior Scientist (R3) REGULATORY CMC BIOLOGICS to lead regulatory CMC activities for biologics programs in a hybrid work environment in the United States. The role focuses on delivering regulatory milestones across product development and...Regulatory
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- ...of GDMS Process & Quality Management to lead development, implementation, and oversight... ...management activities. Reporting to the Head of Global Data Management and Standards, this role... ...quality/compliance groups to ensure audit readiness, CAPA #J-18808-Ljbffr Regulatory JobsRegulatory
$117k - $201.25k
...Development Job Sub Function Regulatory Science Job Category... ...a Principal Scientist, CMC Regulatory Affairs -... .... This position is a hybrid role and can be located... ...programs, synthetic or biologic products, and products... ...approval programs), and Global Regulatory Team. This role...RegulatoryLocal areaImmediate start- ...Senior Scientific Publication Manager in North Wales, PA to oversee global publication strategies and ensure timely, high-quality... ...scientific data. The role requires strong collaboration across teams, a hybrid onsite schedule (3 days on site), and adherence to industry...SuggestedHourly pay
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- ...Health Data Space program within Clinical Data Transparency, defining strategy, governance, and an implementation roadmap across regulatory, legal, technology, and business teams. This role requires 7+ years of program leadership in pharma/healthcare, an advanced degree...Regulatory
$71.9k - $113.2k
Job DescriptionAssociate Scientist, Process Analytics Lab Lead, Biologics Drug Substance CommercializationJoin Our Team as a Biologics Process... ...in compliance with safety, environmental, quality, regulatory, and Process Safety Management requirements.Cross-Functional...RegulatoryFull timeFor contractorsLocal areaFlexible hours- Scorpion Therapeutics is seeking a Senior Scientist, Global Labeling Lead to develop and maintain compliant labeling content for development... ...teams, provide strategic labeling guidance, and act as the regulatory labeling contact for global submissions, shaping labeling...Regulatory
- Johnson & Johnson Innovative Medicine offers a hybrid Manager, Regional Regulatory Affairs - C-ROSS role. You will drive regional regulatory strategy, participate in global teams, and lead regional efforts across multiple regions. The position requires broad regulatory...RegulatoryLocal area
- ...PSTS). This position is a hybrid role and can be located... ...and ultimately through global registration. Principal Responsibilities Lead PSTS project teams of nonclinical... ...Accountable for global regulatory nonclinical documents... ...and Controls (CMC) functions to assure drug...Regulatory
- Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to design and implement worldwide regulatory strategies for Immunology programs. You will be the sole global contact, coordinating with FDA/EMA and regional affiliates to optimize labeling and...RegulatoryWorldwide
$118.3k - $219.8k
...Partnerships & Contracts \*\*Hybrid in Horsham, PAApplylocations:... ...other government patent offices globally. The Director will play a key... ...within the partnership* Lead all contract negotiations, renewals... ...Professional provides legal, regulatory, and business information and...RegulatoryContract workTemporary workFor subcontractorWork at officeLocal areaImmediate startWork from home- ...Director, Regulatory Affairs ClinChoice is a global full-service CRO dedicated... ...Regulatory Affairs (Hybrid) on a permanent basis... ...teams. Lead client interactions... ...with CBER and global biologics experience highly desired... ...including Development, CMC, Labeling,...RegulatoryPermanent employment
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- ...Corporate Governance & Compliance Lead 125-150,000 and Bonus Blue... ...compliance within a legal counsel or at a global law firm to support Board operations, regulatory filings, and corporate governance... ...Situation: This will be hybrid with 3 days a week in the office....RegulatoryPermanent employmentFull timeWork at officeRelocationRelocation package3 days per week
- MSD Malaysia is seeking an Associate Director for Global Oncology Communications to lead external communications for late-stage oncology assets and data... ...setting. The candidate will manage communications for regulatory milestones, supervise crisis communications, and...Regulatory
- ...contingent labor as a variable cost.Job Description• Flex position in Global Labeling, for a Global Labeling Product Leader for the... ...packaging components (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling...RegulatoryWork at officeImmediate startFlexible hours
- ...of GDMS Process & Quality Management to lead the development, implementation, and oversight... ...executive role reports to the Head of Global Data Management & Standards and sets the... ...timely, high-quality delivery of services and regulatory compliance across the organization. #J-18...Regulatory
- ..., Nonclinical Safety Leader (PSTS) in a hybrid role based in Spring House, PA or Cambridge... ...projects from target identification to regulatory submission. You will collaborate with... ...assessments, and mentor teams while engaging with global stakeholders to drive safe, effective...Regulatory
- ...Hybrid Law Firm Partner Privacy Salary Range of 225K-250K Plus... ...where experienced attorneys can lead and grow. The Privacy and Data... ...matter expertise in domestic and global privacy laws (GDPR, CCPA/CPRA,... ..., breach notification, and regulatory investigations Familiarity...RegulatoryFlexible hours
- Merck & Co., Inc. invites students to join the Global Medical Information (GMI) team through the Future Talent Program. This 12-week internship offers hands-on projects and exposure to FDA regulatory processes in medical information and material reviews. You will respond...RegulatoryInternship
$142.4k - $224.1k
...Associate Principal Scientist Regulatory Cmc - Biologics (R4)-Synthetic Moieties (... ...Serve as a Regulatory CMC Lead for the Synthetic-Moiety (Drug... ...execute robust, phase-appropriate global Regulatory CMC strategies... ...Work Arrangements: Hybrid Shift: 1st - Day Valid...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...We are searching for the best talent for Global Medical Affairs Leader (GMAL) Psoriatic... ...medicines of tomorrow. Our Immunology team leads in the development of transformational... ...is located in Horsham, PA and follows a hybrid schedule of three days in the office and...Work at officeLocal areaRemote workWorldwide2 days per week
- ...seeking an Associate Director, Regulatory Affairs - Power Platform Solutions Specialist to lead the configuration and optimization... ...Power Platform within Global Regulatory Affairs and Clinical... ...secure regulatory solutions, with hybrid work and travel approximately...Regulatory
$258.83k - $293.48k
...Madrigal Pharmaceuticals seeks a Senior Director of Regulatory Affairs CMC to lead strategy and execution for chemical manufacturing and controls... ...deep expertise in small molecule regulatory development and global health authority interactions. Responsibilities Independently...Regulatory- Role The Global Marketing Director leads commercial strategy development for a novel... ...collaborations with clinical, regulatory, medical, market access,... .... High-Value Oncology, biologics, early development (pre-IND... ...launch execution. Work Setup hybrid model with 15-20% travel....Regulatory
$71.6k - $119.4k
...environments. This role serves as a technical lead for complex infrastructure initiatives,... ...near the Horsham, PA location for a Hybrid onsite scheduleAccountabilitiesDesign, implement... ...Legal & Professional provides legal, regulatory, and business information and analytics...RegulatoryFull timeLocal areaImmediate startWorldwideFlexible hours- ...Director, Project Manager, leads end-to-end drug development... ...alignment among clinical, regulatory, manufacturing, CMC, and commercial teams, and... ...stakeholder management across global teams (including Japan and... ...Upper Gwynedd, PA, with a hybrid work setup and approximately...Regulatory
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