- Scismic (Boston, MA)
- …company that is discovering and developing novel medicines for cancer.We are seeking an Associate Director / Director of Regulatory Affairs to join the ... development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. This role will lead US submission work.Your role:You will… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …advanced degree preferred.At least 8+ years of regulatory affairs experience for the associate director or 10+ years of Regulatory affairs experience for ... The position is responsible for supporting and leading activities within Regulatory Affairs department, to support clinical development of oncology products at ORIC.… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …range for director level candidates is between $200,000-$235,000 and associate director level candidates is between $160,000-$180,000. The final salary ... important to us as an organization.The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all… more
- Merck & Co. (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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible ... provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Associate Director of Regulatory Writing is a key role ... provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU… more
- Tris Pharma (Monmouth Junction, NJ)
- …Administration (FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , ... Associate Director / Director , Analytical Research...She/he also reviews and approves all scientific, technical and regulatory packages per International Council for Harmonization (ICH)/Food and… more
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Associate Director , Policy Strategy and Capabilities The Associate Director , Policy Strategy and Capabilities is ... team, reporting to the Executive Director , Policy Development & Strategy.The Associate Director will develop and maintain the strategic planning digital… more
- Takeda (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide.As an Associate Director , Global Regulatory Affairs Marketed Products you will ... initiatives and influencing the field as applicable.How you will contribute:The Associate Director will be responsible for increasingly complex or… more
- Takeda Pharmaceutical (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will ... initiatives and influencing the field as applicable. How you will contribute: The Associate Director will be responsible for increasingly complex or multiple… more
- ClickJobs.io (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will ... initiatives and influencing the field as applicable. How you will contribute: The Associate Director will be responsible for increasingly complex or multiple… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide.As an Associate Director , Global Regulatory Affairs Marketed Products you will ... initiatives and influencing the field as applicable.How you will contribute:The Associate Director will be responsible for increasingly complex or… more
- Ascendis Pharma A/S (Palo Alto, CA)
- The Regulatory Affairs (RA) Associate Director , Labelling will be responsible for labelling activities across programs and stages of development, with ... the Americas and supporting global needs as required.The RA Associate Director , Labelling will be overall responsible...for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to… more
- Avidity Biosciences (San Diego, CA)
- Job Title: Associate Director - Regulatory AffairsLocation: San Diego, CA / Hybrid / RemotePosition type: Full timeFLSA: ExemptDepartment: Regulatory ... and engage with us on LinkedIn and Twitter.The OpportunityThe Associate Director , Regulatory Affairs is responsible for establishing … more
- Gilead Sciences, Inc. (Foster City, CA)
- Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory AffairsJob DescriptionAt Gilead, we're creating a healthier ... their aspirations. Join Gilead and help create possible, together.Job DescriptionThe Associate Director , Analytical Regulatory Science, collaborates with… more
- Monte Rosa Therapeutics (Boston, MA)
- …highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on ... to support the global development and approval of our innovative therapies.ResponsibilitiesThe Associate Director of Regulatory Affairs will be responsible… more
- Avidity Biosciences, Inc. (San Diego, CA)
- Job Title: Associate Director , Regulatory AffairsLocation:San Diego, CA / Hybrid / RemotePosition type:Full timeFLSA:ExemptDepartment: Regulatory and ... and engage with us on LinkedIn and Twitter.The OpportunityReporting to the Director , CMC Regulatory Affairs, the successful candidate will work independently… more
