- Merck & Co. (North Wales, PA)
- …Global Regulatory Submissions, Management Process, People Leadership, Product Lifecycle, Regulatory Affairs Compliance, Regulatory Affairs ... this role will be accountable to ensure a holistic Regulatory centric D ata M anagement ( R DM)...Fa nd EMA PMS) - Represent the Company in international trade association committees and meeting groups associated with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations,… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Problem Solving, Process Improvements, Project Management, Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, ... Job DescriptionReporting to the Customs & International Trade (CIT) Tariff Classification Associate Director, the Senior Specialist will work closely with our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA oversight.Drive innovative process improvements across RD, PV, and Medical Affairs by leveraging emerging technologies and industry best practices.Ability to ... and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as those from Quality Events, Audits Findings and … more
- Merck & Co. (Rahway, NJ)
- …Project Management, Project Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, ... Job DescriptionDescription Reporting to the Customs & International Trade (CIT) Valuation Associate Director, the Senior Specialist position's core responsibilities… more
- Tris Pharma (Monmouth Junction, NJ)
- …medical writing guidance and supports cross-functional teams (ie, clinical development, regulatory affairs , biostatistics, external vendors, etc.) Oversees, and ... pain and addiction addressing unmet patient needs. We have more >150 US and International patents and market several branded ADHD products in the US We also license… more
- Genmab (NJ)
- …Management, Clinical Operations, Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data strategy with ... protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead… more
- Eisai, Inc (Raleigh, NC)
- …or site manufacturing changes in collaboration with Product Quality, Regulatory Affairs , and Technical Operations.Establish productive business relationships ... interface experiences with the Finance, commercial Sales and Marketing organizations, regulatory affairs , and with third party manufacturers.Strong knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents ... clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions. Contributes to CDx… more
- Merck & Co. (North Wales, PA)
- …is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Genmab (NJ)
- …with key stakeholders within Global Development Operations (GDO), Medical Affairs , Medical, and/or CROs, to enable expedited, predictive delivery for ... and tactical operational plans aligned to the commercial and regulatory objectives.Excellent stakeholder management, concise written communication, ability to… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Senior Manager, International Regulatory Affairs , you will be responsible for Central Asia, South Asia, and Japan (CASAJ) and ... for new and existing products to ensure compliance with international regulations. + Coordinate, prepare, and review regulatory...You:** + Minimum BA/BS required. + Minimum 8 years regulatory affairs experience; or a combination of… more
- Medtronic (Mansfield, MA)
- …development and review process + Provide business and product information to the international regulatory affairs team to enable development and strategies ... Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team...+ Review promotional and advertising material + Maintain current regulatory knowledge of domestic and international regulations,… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will ... monitor their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - International Compliance Operations** will provide support… more
- Hologic (Newark, DE)
- …with US, EU and Canadian regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions ... Regulatory Affairs Specialist 4 Newark, DE, United States **Why Hologic?** Hologic empowers people to live healthier lives everywhere, every day. We are the… more
- AbbVie (Irvine, CA)
- …+ Supports regulatory interactions with R&D, Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director of Regulatory Affairs - Soft Tissue Fillers supports regulatory … more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …* Play an active role in supporting the execution of key projects within the International Government & Regulatory Affairs Team and broader Global External ... accommodation to individuals with disabilities. **Brief Job Overview** The Senior International Regulatory Intelligence Manager will lead the development and… more
- Lundbeck (Deerfield, IL)
- …+ Global Regulatory Affairs Experience. + Exposure to international regulatory affairs , including participation in submissions to ex-US ... to candidates anywhere in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the… more
- Takeda Pharmaceuticals (Boston, MA)
- …in which biopharmaceutical companies operate + Extensive experience in US and/or International Regulatory Affairs , including experience with INDs, BLAs/NDAs, ... provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health Authorities in Japan,… more
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