- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical / FDA Communications.Assists the Senior ... communications/ updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs / FDA Communications in managing, coordinating,… more
- Merck (Rahway, NJ)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... drug development or clinical experience, preference if this experience is in regulatory affairs . + Excellent communication skills (both oral and written). +… more
- Stryker (Mahwah, NJ)
- …We are currently seeking a **Senior Regulatory Affairs Specialist** to join ... regulatory agencies and notified bodies. The Senior Regulatory Affairs Specialist is the Regulatory...for responsible products/technical files + Author and submit electronic regulatory submissions for the FDA and Notified… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide ...if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Bayer (Whippany, NJ)
- …Code:** 832367 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Compliance, Radiology, Regulatory Affairs , Clinical Research, Medical Research, ... knowledge to US Medical Strategy, Marketing, New Development, US Regulatory Affairs , Communications, Legal and Global Medical...press releases; + S/He will contribute to post approval regulatory required trials by the FDA . This… more
- Merck (Rahway, NJ)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs Liaison is responsible for development...to facilitate initial approval by agencies for conduct of clinical trials + Participate in regulatory due… more
- J&J Family of Companies (Raritan, NJ)
- …of local labels as appropriate. + Provides regulatory input to clinical development programs, risk/benefit assessments, and medical affairs programs. + ... strategies are in alignment with product portfolio, regional strategies, CMC- Regulatory Affairs strategy, commercial and market access...+ Serve as primary point of contact for US FDA + Lead the regulatory response team… more
- Catalent Pharma Solutions (Somerset, NJ)
- …NJ is hiring a Senior Regulatory and Compliance Specialist for the Regulatory Affairs Group. The Senior Regulatory and Compliance Specialist candidate ... Assurance, Pharmaceutical Manufacturing, or Compliance + Knowledge of US FDA regulatory requirements as it pertains to...a regulated field is required + Deep understanding of FDA and cGMP regulations pertaining to clinical … more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …other relevant technical degree with minimum 10 years of leadership experience in clinical affairs . Advanced degree (eg MPH, PhD) preferred.* Previous experience ... SOCRA or ACRP credential highly preferred* Broad knowledge and experience with clinical affairs regulations and implementation.* Demonstrated track record of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all ... Gilead and help create possible, together. **Job Description** **_CLINICAL OPERATIONS_** _: Clinical Operations is responsible for the execution of all Phase 1-4 … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety &...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Terumo Medical Corporation (Somerset, NJ)
- …work with stakeholder departments such as Engineering, Operations, Clinical , Medical Affairs and Regulatory Affairs on Post Market Surveillance strategy ... products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety &...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate ... trends, legislative changes, and guidelines issued by global regulatory agencies ( FDA , EMA, MHRA, etc.) related...and drug coding conventions (MedDRA, WHO-DD) - Knowledge of FDA and global PV regulations, clinical and… more
- Sanofi Group (Morristown, NJ)
- …of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and other health authorities. + Collaborate ... work in close partnership with other departments including brand teams and Public Affairs + Play a leadership role in developing, executing, and contributing to the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Liaisons to ensure successful implementation of CDx and data collection + Supports Regulatory affairs in providing content and providing review of documents ... technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads...supporting CDx submissions to the FDA and other health authorities globally + For late-stage… more