- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... development of regulatory strategies to ensure effective achievement of regulatory /business objectives. The Executive Director will direct the development… more
- Merck & Co. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance with global regulations and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Omnicom Health (New York, NY)
- …closer to patients. Together, we accelerate the impact of science. Associate Scientific Director ( Regulatory ) We are seeking a seasoned Associate Scientific ... of four powerhouses- Commercial & Marketing, Medical Affairs, Publications, Regulatory - that enables hyperconnected, audience-centric engagement that delivers… more
- ADMA BIOMANUFACTURING LLC (Boca Raton, FL)
- …ADMA Biologics. We currently have an exciting opportunity available for an Associate Director , Regulatory Affairs - Plasma Services in Boca Raton, Florida! The ... Associate Director , Regulatory Affairs - Plasma Services is responsible for the regulatory compliance of the Plasma Services Organization. Acts as the… more
- Fate Therapeutics, Inc. (San Diego, CA)
- Fate Therapeutics is looking for an Executive Director or Senior Director in Regulatory Affairs to oversee and direct the strategic planning and execution of ... clinical regulatory activities essential for initiating and conducting clinical trials...essential for initiating and conducting clinical trials and securing regulatory approvals. This role involves extensive interaction with … more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be... Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… more
- BioSpace (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing ... innovative global regulatory strategies and providing strategic regulatory guidance...and Takeda R&D. How you will contribute: The Associate Director will be responsible for increasingly complex or multiple… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Pall (Miami, FL)
- …innovation.Learn about the Danaher Business System which makes everything possible. Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets ... of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant ... cross-functional teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation, ensuring all processes align with… more
- Merck & Co. (Rahway, NJ)
- …West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our robust infectious disease and vaccines pipeline. - As an ... Associate Director , you will represent QP2 on cr o ss-...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. ... with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that ... ingredients (API), biologics, vaccine drug substances and finished products. As Director , you will support Quality audits and health authority inspections and… more
- Insmed Incorporated (San Diego, CA)
- …on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of the ... technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating method characteristics… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary Under the guidance of an Executive Director , has primary responsibility for developing value evidence strategies, and planning/managing ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… more
