- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... 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
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport ... Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs...and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning ... & ManagementEisai Salary Transparency Language:The base salary range for the Associate Director , Medical Education - Oncology is from :162,600-213,400Under… more
- Eisai, Inc (Atlanta, GA)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Access and Reimbursement (AD ARM) will lead the Eisai Access and ... Resources Department.Skills:Eisai Salary Transparency Language:The base salary range for the Associate Director , Access & Reimbursement - (Southeast) is from… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver ... affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improving the lives of more patients than ever before. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has ... Expert understanding of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well as the… more
- Merck & Co. (Upper Gwynedd, PA)
- …leadership of cross functional teams compromised of Global Supply Chain, Global Regulatory Affairs , Labeling, Material Master Data, Finance, Quality, Transfer ... of switch plans with all relevant stakeholders (Donor & Receiving Sites, Global Regulatory Affairs (Labelling), Quality and the Material Master Data Management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director , Strategic Collaboration role is responsible for fostering partnerships ... of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well...medical, access, public affairs , compliance, legal and regulatory as well as the healthcare ecosystem We commit… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strong collaborators, as we embark on shaping our future. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has ... Rare Bleeding Disorders TA lead (A/B). Works closely with Associate Directors and Sr Brand Managers across the Rare...of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well… more
- Genmab (NJ)
- …readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide oversight ... we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is...Clinical Operations, Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the ... necessary information to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external stakeholders.… more
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will ... CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be ... and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties + Act as the Global… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- AbbVie (Mettawa, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising ... cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …a **maker of possible** with us. **Summary of Job Responsibilities** The Associate Director of Regulatory Affairs will provide regulatory support for ... regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling existing product registrations including… more
