- 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs provides strategic global regulatory guidance to ... requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg,… more
- Ascendis Pharma (Princeton, NJ)
- …working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an internal expert on ... the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is responsible for providing… 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
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful difference in ... incumbent will be assigned to lead/support one or two clinical development programs as Regulatory Lead (RL),...and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares… more
- Novo Nordisk (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... About the Department The Clinical , Medical and Regulatory (CMR) department...and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ… 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
- Mount Sinai Health System (New York, NY)
- … Regulatory Coordinator will be responsible for supporting the regulatory affairs team to ensure compliance with FDA regulations, ICH-GCP guidelines, and ... regulatory ); MS degree or advanced certification in regulatory affairs or clinical research...Proficient with MS Word and Excel + Experience with FDA , EMA or other global health authority submissions is… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Operations, Chemistry, Manufacturing and Controls (CMC), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing departments. + Identifies suitable ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and...any current or potential new CPOs. + Collaborates with Regulatory Affairs to provide all documents required… more
- Caris Life Sciences (New York, NY)
- …responsible for clinical data entry activities for the Caris Medical Affairs protocols and projects at the Caris Precision Oncology Alliance sites. The position ... clinical database. + Support and adhere to Good Clinical Practices (GCP) guidelines, FDA , Institutional Review...years of experience in data collection activities within a GCP/ clinical research regulatory environment. + Knowledgeable in… 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
- Ascendis Pharma (Princeton, NJ)
- …programs, competitive landscape, new therapies, clinical trends, and newly issued regulatory rules and FDA guidance to promptly identify any potential impact ... advocacy groups. + Work with internal stakeholders including Commercial, Legal, Regulatory , Clinical Development, Clinical Operations, Compliance,… more
- Novo Nordisk (Plainsboro, NJ)
- …Internal stakeholders: Global Safety, QPPV office, Global Development, Product Supply, Regulatory Affairs (NNI/NNCI) marketing, legal and NNI Patient Support ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Taiho Oncology (Princeton, NJ)
- …preferred. Knowledge, Skills, and Abilities: + 8-10 years Hematology / Oncology Medical Affairs and Clinical experience preferred. + At least 2-5 years' ... and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources… more