Executive Director, Biologics CMC Regulatory Strategy
MSD Malaysia
MSD Malaysia is seeking an Executive Director for Regulatory Affairs based in Rahway, NJ. This role involves overseeing the regulatory CMC team and ensuring successful development of CMC regulatory strategies for biologics products. The candidate will be responsible for managing CMC submissions, leading cross-functional teams, and influencing regulatory strategies. A Ph.D. is preferred alongside extensive experience in CMC and regulatory affairs. #J-18808-Ljbffr
- Associate Principal Scientist, Regulatory CMC - Biologics (R4) Responsibilities Implement Chemistry,... ...Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises in... .../policies and timelines. Develop and execute global regulatory strategies for...Regulatory
- ...Scorpion 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...Regulatory
- ...MSD Malaysia in Rahway, NJ, seeks a Director of Engineering responsible for leading the Development and Commercialization Team (DCT) to deliver integrated CMC strategies for biologics. You will ensure robust execution and influence stakeholders in achieving strategic product...Suggested
$231.9k - $365k
...Executive Director, Microbiology The Executive Director, Microbiology... ...small molecule, biologics and vaccine... ...sites, and support for regulatory filings including INDs... ...& Development teams; CMC and Regulatory functions... ...microbiology and control strategies. Oversight of all raw...RegulatoryFor contractors$255.8k - $402.7k
## Executive Director, Regulatory AffairsApplyremote type: Hybridlocations: USA - New Jersey - Rahway... ..., Manufacturing, Control for Biologics (Biologics-CMC) is accountable for managing a team... ...ensuring rigor in CMC regulatory strategy as well as delivery of high quality...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hours- Merck & Co. is seeking an Associate Principal Scientist in Regulatory Affairs, based in Rahway, NJ. The role involves developing and implementing CMC regulatory strategies for our pharmaceutical pipeline, focusing on respiratory and inhalation product development. The...Regulatory
$190.8k - $300.3k
Merck & Co. seeks a Director/Principal Scientist for Device Regulatory Affairs, focusing on the regulatory framework for... ...over 10 years of experience in biological or pharmaceutical research, with excellent... ...extensive knowledge of regulatory CMC procedures. #J-18808-Ljbffr Merck...RegulatoryRemote work- Associate Principal Scientist (Assoc. Director), Regulatory Affairs - CMC Company: Merck & Co. Location: Rahway, NJ. Job Description: Global Regulatory... ...for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance...Regulatory
$231.9k - $365k
...Job Description The Executive Director, Network Strategy Execution (NS&E) and Product Source Management is responsible for setting the strategic... ...stakeholders across Operations, Supply Chain, Quality, Regulatory, Technical, Finance, Global Engineering Services and other...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...technical leadership for late‑stage biologics programs with a focus on... ...and cell banking‑related regulatory strategy, filing authoring, and... ...line development, late‑stage CMC program support, regulatory... ...biologics programs. Design and execute pre‑LIVCA studies, coordinate...RegulatoryFor contractors- MSD Malaysia is seeking an Executive Director of Microbiology to provide strategic and technical leadership across the clinical development... ...release, stability activities, and method transfers, ensuring regulatory compliance. The ideal candidate will have a Ph.D. in...Regulatory
- ...Inc. is seeking a Chief of Staff to support the operational backbone of a boutique life sciences advisory firm specializing in regulatory strategy for innovative therapies. The role involves strategic partnership with the CEO, overseeing business process design, and...Regulatory
- ...Executive Director, PAM and Identity Governance Iselin, New Jersey, United States CLS is... ...Understand, interpret and apply regulatory requirements, compliance and industry... ...alignment with the overarching security strategy. Define the policies and standards...RegulatoryWork at officeWork from homeFlexible hours
$231.9k - $365k
...as a member of their Leadership Team, the Executive Director, Functional Area Geography Lead leads global geographic strategy and performance across assigned region/ geography... ...excellence in functional management and regulatory compliance, while embodying ELS (Enterprise...RegulatoryFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- ...MSD Malaysia is seeking an Associate Director, Regulatory Affairs to support oncology products through effective regulatory strategies. The role requires excellent communication and collaboration skills, along with expertise in drug development and regulatory agency interactions...Regulatory
- ...derived from the largest single source of FX executed data available to the market. Our... ...evolving cyber threats and stringent regulatory requirement. Define and drive the overarching Cyber Hygiene and Data strategy and framework for CLS, setting the vision...RegulatoryWork at officeWork from homeFlexible hours
$255.8k - $402.7k
...Executive Director – Oncology Clinical Development The Executive Director has primary responsibility... ..., execution, monitoring, analysis, regulatory reporting, publication, and... ...applications. Develop clinical development strategies for investigational or marketed vaccines...RegulatoryFor contractorsWorldwide$231.9k - $365k
...is seeking a Team Leader (Executive Director) to support our rapidly expanding... ...pharmacology global regulatory landscape to oversee and deliver... ...and life-cycle management strategies with QP2 pharmacometric... ...engineering, computational biology, or a related field Immunology...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...Job Overview Associate Director, Regulatory Affairs supports products in the... ...develop and implement a global strategy for registration and/or... ...Manufacturing and Control (CMC), and other functional areas... ...related doctoral degree in a biological science, chemistry, or related...RegulatoryFor contractors- ...Description Job Description Salary: Executive Director of Friends MISSION: The... ...budgets, schedules, milestones, and funding strategies Coordinate procurement and... ...necessary permits, zoning approvals, and regulatory compliance for construction projects...RegulatoryTemporary workFor contractorsLocal area
$310.9k
Executive Director (Distinguished Scientist) - Product Development Team Lead Lead planning and execution... ...from Phase 2 to Phase 5, including strategy, design, protocol development, execution, monitoring, analysis, regulatory reporting, and publication. Provide scientific...RegulatoryFor contractors$310.9k
Executive Director (Distinguished Scientist) - Oncology/Hematology This position leads the Product... ...Phase 2 to Phase 5, including program strategy and design, protocol authoring,... ...initiation, execution, monitoring, analysis, regulatory reporting, publication, presentation...RegulatoryFor contractorsWorldwideFlexible hours- ...Executive Director Of Behavioral Health & Detox Services The Executive Director of Behavioral... ...behavioral health and addiction care strategy across all HRHS sites and programs.... ...hospitals and outpatient practices. Ensure regulatory compliance, quality outcomes,...Regulatory
$182.15k
...Description: We are seeking a Managing Director to join the Assurance Professional... ...leading the Firm's Quality Management (QM) strategy for the assurance practice. This team is... ...you will operate at the intersection of regulatory compliance, audit quality, and operational...RegulatoryWork at officeLocal areaWorldwide$150k
...collaborative leader to serve as its next Executive Director. This is a unique opportunity to... ...Director will oversee organizational strategy, fundraising, operations, and community... ...compliance with all applicable legal, regulatory, and funding requirements. Qualifications...RegulatoryFull timeContract workLocal area$33.03 - $41.95 per hour
...Document Specialist to support CMC documentation for a late-... ...Management Office and will support regulatory submission activities,... ...sections aligned with regulatory strategy for clinical and life-cycle... ...Bachelor’s degree required; Biology or related discipline preferred...RegulatoryHourly payContract workWork at officeLocal areaMonday to Friday- ...Neier Inc. is seeking a Director/Principal Scientist for their Devices and Drug-Device Combinations Regulatory CMC team. This role involves supporting regulatory activities for the company's autoinjector and inhalation products, ensuring adherence to global regulations...Regulatory
- ...client is a boutique life sciences advisory firm focused on regulatory strategy for first-of-their-kind therapies, with deep expertise supporting... ...new drug applications and new drug application or biologics license application filings. The Chief of Staff will play a...Regulatory
- ...Executive Director, Global Patient Safety Sciences Delivery At Regeneron, we use science and... ...Discover your role: Define the strategy to ensure standardization and consistency... ...Regeneron interfaces (e.g., Clinical, Regulatory, Med Affairs, Biostats & Data...RegulatoryWorldwide
- ...Executive Director, Commercial Insights and Analytics Ophthalmology At Regeneron, we use science... ...to contribute to ongoing brand strategies and decisions, including long-term data... ...Demonstrated knowledge of the legal and regulatory environment, as it relates to commercialization...RegulatoryWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Biologics CMC Regulatory Strategy. Be the first to apply!


