- Merck (Rahway, NJ)
- …Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose ... and stakeholders in development. The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 10-15 direct reports composed of… more
- Merck (Rahway, NJ)
- **Job Description** The Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a ... guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses ( biologics license application submission) and… more
- Merck (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent… more
- Novo Nordisk (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide ... positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion....+ A minimum of 7 years of experience in pharmaceutical/ biologics industry or related field required, with 5 years… more
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Associate Director , Global Regulatory Affairs? The job is located in our ... is a hybrid position. You will report to the Director of Global Regulatory Affairs. **Responsibilities:** You...10+ years of experience in the pharmaceutical industry in Biologics /Research & Development, some experience may be accounted for… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics , Biosimilars, and Small Molecules.Ensure alignment with ... Description: Subject matter expert in the area of Biologics . Promotes and develops initiatives to continually improve working relationships within and across… more
- Takeda Pharmaceuticals (Boston, MA)
- … review in due diligence for licensing opportunities. + Strong knowledge of global regulatory requirements for drugs and biologics . + Ability to function as the ... with a minimum of 5 years of within a regulatory strategy role + Plasma or biologics experience preferred + Preferred experience in reviewing, authoring, or… more
- Merck (Rahway, NJ)
- **Job Description** The Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... molecules and biologics , as well as creating and maintaining reference data...will play a pivotal role in meeting cross-divisional and regulatory requirements by their strong scientific background, excellent communications… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director of Training **Grade:** L3-2 **About the Job** The Sanofi Genzyme ** Associate Director of Field Learning and ... the Sanofi Director of Field Learning (Foundations and Emerging Therapies). The Associate Director of Field Learning and Development role is based in… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill an Associate Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive ... and ensure we are performing with in compliance. The Director will also provide support during regulatory ...a quality driven organization + Have an understanding of biologics manufacturing operations To be considered for this role… more
- Merck (Boston, MA)
- …component of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. This ... Associate Director will work with scientists within...+ Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics ,… more
- Merck (Millsboro, DE)
- **Job Description** Our company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory...animal facilities and program reviews is required. **Purpose** This Associate Director will report to the Site… more
- Merck (Columbus, OH)
- …Pharmacology and Pharmacometrics -** **Immune/Oncology** **(QP2-IO)** team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- AbbVie (Barceloneta, PR)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director of Quality Control Laboratories is responsible for ... in science and 10 + years of relevant experience in quality/ regulatory in pharma, biologics , or equivalent regulated industry or Master's degree and 8+ years… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **PURPOSE AND SCOPE OF POSITION:** The Associate Director , CTF Digital Plant IT Quality at Devens Cell ... COMPETENCIES: Knowledge, Skills, and Abilities** + Thorough knowledge of regulatory computer system validation requirements including FDA, EMA, and Worldwide… more
- Merck (West Point, PA)
- …Reporting to the Director of Packaging Commercialization, the Associate Director , Engineering, Packaging Commercialization will lead packaging development ... prior experience developing and commercializing new products on cross-functional teams. The Associate Director will be accountable for the definition and… more
- United Therapeutics (Columbus, OH)
- …cardiovascular and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key role in ... Strategy: Evaluate, strategize, and execute process changes in response to regulatory updates, ensuring the effectiveness and efficiency of end-to-end commercial… more
- Bristol Myers Squibb (Princeton, NJ)
- …and successful marketing authorizations across the globe. PCO "is looking for a Scientific Associate Director to join the Dev DMPK group that is an expert ... pharmacokinetics activities of multiple projects; be responsible for preparation of regulatory dossier/responses; and assist in developing strategy for the group.… more
- Rhythm Pharmaceuticals (Boston, MA)
- …overcome barriers, together. Opportunity Overview Rhythm Pharmaceuticals is seeking an Associate Director , Non-Clinical Research to join the Translational ... to overall company strategy. This role will report into the Sr. Director , Non-Clinical Development. Responsibilities and Duties + Support and oversee Rhythm's… more
- Bristol Myers Squibb (Summit, NJ)
- …no better place than here at BMS with our Cell Therapy team. The Associate Director , Drug Product External Manufacturing QA provides Quality oversight to ... technology transfer and routine operations and ensure CMO(s) remains compliant to regulatory requirement and BMS procedures. **Shift Available:** + Monday - Friday,… more
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