- Merck & Co. (North Wales, PA)
- …for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist /...to Regulatory CMC leadership team as appropriate.Provide regulatory leadership as needed in product in-license/due… more
- Merck & Co. (North Wales, PA)
- …the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of the ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Merck & Co. (North Wales, PA)
- …Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory strategy to optimize label and obtain shortest time ... regulatory agencies for multiple indications simultaneously.Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL,… more
- Merck & Co. (Rahway, NJ)
- …following: Technology, Manufacturing Operations, Finance, Regulatory , Quality, Compliance , Supply Chain and Commercial.Understanding of product development ... Management (VCM) is the accountable organization for our company's Manufacturing Division product supply chain strategy in alignment with Global Human Health (GHH)… more
- Merck & Co. (Rahway, NJ)
- …cross-functional colleagues to create innovative and intuitive-to-use products and ensure regulatory compliance through risk management. The cross functional ... team includes marketing, product planning/project managing, formulation development, clinical, safety, regulatory...and maintenance of documents, records and databases that support regulatory compliance (such as human factors study… more
- Aequor (Golden Valley, MN)
- …raw material specification and ISGA approval and verification of terminology Assist with product recalls Support Director Regulatory Affairs on an as-needed ... This Regulatory Specialist role will support the Director Regulatory Affairs in the regulatory...regulatory guidance in project meetings and support the regulatory department in our compliance activities. … more
- Merck & Co. (Rahway, NJ)
- …software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product development to ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… more
- Merck & Co. (Rahway, NJ)
- …numerous internal cross-functional product development teams from concept through product launch and post market surveillance.-This Director role is ... Job DescriptionThe Director , Device System - Design Control plays a...within Device Development and with external suppliersUnderstand and apply regulatory / compliance requirements relative to design… more
- Merck & Co. (Rahway, NJ)
- …organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early Drug Development and/or ... & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Merck & Co. (Rahway, NJ)
- …chemical and biochemical processes, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends ... R&D and DSCS. --The candidate will have experience in an innovative analytical/ regulatory /GMP environment.The Director will effectively team with the SMAR&D… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and evaluates IT systems risks and vulnerabilities, applying expert knowledge of compliance with all security, regulatory , and quality policies and procedures, ... with senior internal and external personnel on technical matters. Understanding of regulatory agency and compliance requirements (FDA) in a pharmaceutical… more
- Aequor (Devers, TX)
- Sr. Director , IT Cell Therapy Devens Manufacturing Site (DVN 2024) Salary Range: $223K to $262K &plus 25% annual Bonus &plus Long-term incentives of 85000 Position ... Summary The Sr. Director , Cell Therapy Devens Manufacturing Site IT Lead position...seeking a highly skilled and experienced IT Platform and Product Manager to oversee the IT operations at our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , AR&D serves ... Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc.… more
- Merck & Co. (Rahway, NJ)
- …critical business needs, which can include impact of the external business, regulatory , and compliance environment. Promoting our company's scientific excellence ... Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway,...materials, package components, clinical drug substance, and clinical drug product for our small molecule portfolio. In this role,… more
- Merck & Co. (Rahway, NJ)
- …the Director will work closely with internal stakeholders-including sales, product development, and regulatory teams-and external partners to ensure cohesive ... Job DescriptionSummary of PositionThe Parasiticides Marketing Director will manage a complex go-to-market strategy across a diverse portfolio of leading brands in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Eisai, Inc (Raleigh, NC)
- …This also involves building effective quality systems and continuous improvement activities. Regulatory Compliance : Ensure compliance with all company ... PPQ, PAI Readiness, and Quality System Oversight Implementation.Audit and Compliance : Maintain audit readiness, support regulatory inspections, manage… more
