- Altimmune, Inc. (Gaithersburg, MD)
- …and intranasal vaccines (NasoVAX (TM) and NasoShield (TM) ). Job Description: The Director , Regulatory Affairs will lead development of regulatory strategy, ... build processes to ensure global regulatory compliance, and manage all regulatory submissions and interactions. The Director will prepare for meetings,… more
- Orchard Therapeutics (Boston, MA)
- …. The Role As part of our on-going growth, we are currently recruiting for a Sr Director , Regulatory Science to join the regulatory team in order to lead ... Location: Boston, MA Reporting to: Chief Regulatory Officer (London, UK) The Company: Orchard Therapeutics...US submissions. This role will report to the Chief Regulatory Officer based in London and will be a… more
- Omeros Corporation (Seattle, WA)
- We are a growing and dynamic organization seeking a Sr. Director , Regulatory Affairs to join our Regulatory Affairs team. In this position, you will be ... responsible for leading the Regulatory Affairs function. This includes Regulatory CMC, Regulatory Managers, Regulatory Operations, Technical Writing, and… more
- Mirati Therapeutics (San Diego, CA)
- …immunological drivers of cancer. Role Description: Reporting directly to the Head of Regulatory Affairs and Quality Assurance, the Senior Director , Regulatory ... formulation of regulatory strategy, serve as the regulatory lead on relevant project teams, and act as...lead on relevant project teams, and act as the regulatory contact for US/Global health authorities as required. This… more
- Global Blood Therapeutics (San Francisco, CA)
- SENIOR DIRECTOR , REGULATORY AFFAIRS CMC Position Summary: The Senior Director Regulatory Affairs CMC will report to the Vice President Regulatory ... the Regulatory Affairs CMC group within the Regulatory Affairs function. This includes strategic and operational oversight...strategic and operational oversight of all US and ROW Regulatory Affairs CMC activities, as well as management of… more
- Seattle Genetics, Inc. (Bothell, WA)
- Summary: The Sr. Director , Regulatory Affairs provides strategic regulatory leadership and oversight in support of multiple early and late phase development ... This includes oversight of the development and implementation of global regulatory strategies, ensuring timely preparation, review and submission of documents to… more
- Daiichi Sankyo (Bernards, NJ)
- …Prepare and review annual reports and supplements for marketed products. The Associate Director , Regulatory Affairs will liaise with the review branches of FDA ... age, or any other characteristic protected by law. Job Title Associate Director , Regulatory Affairs City Basking Ridge Functional Area Regulatory Affairs… more
- Emergent BioSolutions, Inc. (Gaithersburg, MD)
- …professional skills to develop products designed-to protect life. JOB SUMMARY The Senior Director , Regulatory Affairs, will be responsible for Regulatory ... management, Regulatory Due Diligence for M&A support and Regulatory Operations. The Senior Director , Regulatory Affairs is responsible for providing the… more
- Daiichi Sankyo (Bernards, NJ)
- … regulatory documents in highly complex technical areas. Job Title Associate Director Regulatory Affairs CMC City Basking Ridge Functional Area Pharma ... structure-guided R&D center in Berkeley, CA. Job Summary: This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the… more
- Daiichi Sankyo (Bernards, NJ)
- …status, age, or any other characteristic protected by law. Job Title Executive Director Regulatory Affairs City Basking Ridge Functional Area Regulatory ... rare diseases. Job Summary: This position is accountable for developing and driving regulatory policy and provides oversight of regional and/or global regulatory … more
- AbbVie (Redwood City, CA)
- …emerging biologic technologies including oncolytic virus' and CAR-T cells. The Associate Director / Director , Regulatory Affairs will develop and implement ... role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global… more
- California Walnut Board (Folsom, CA)
- Director , Regulatory & Technical Affairs The California Walnut Board (CWB), and sister agency, California Walnut Commission (CWC) are walnut marketing and ... research programs. The CWB has a career opportunity for a Director , Regulatory & Technical Affairs. This position contributes to the organization’s success… more
- Daiichi Sankyo (Bernards, NJ)
- …status, age, or any other characteristic protected by law. Job Title Associate Director , Regulatory Affairs Labeling City Basking Ridge Functional Area ... Summary This position serves as the RA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- AbbVie (Mettawa, IL)
- The Associate Director , Regulatory Affairs (RA) Communications and Change Management is responsible for the development, coordination and execution of ... and change management (people, process and technology related) activities for AbbVie's Regulatory Affairs. The Associate Director will lead change management… more
- Jazz Pharma (Philadelphia, PA)
- …our career openings and get to know Jazz Pharmaceuticals. Responsibilities: The Associate Director , Promotional Regulatory Affairs will be a member of Jazz ... tactics for assigned products/teams under the guidance and direction of the Director /Senior Director , Promotional Regulatory Affairs. Works collaboratively… more
- JM Huber Corporation (Atlanta, GA)
- …relentlessly contribute to unlocking our customer’s own success. Position Summary The Director , Regulatory Affairs-Nutrition and Funtional Foods is a key leader ... of our Marketing management team and will provide robust Regulatory leadership to support the development and implementation of regulatory strategies and… more
- Merck & Co. (Rahway, NJ)
- …and solutions to the world. Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for: *Developing regulatory ... Primary activities include, but are not limited to: *Reports to Executive Director , Therapeutic Area Lead. *Develops worldwide product regulatory strategy to… more
- Merck & Co. (Rahway, NJ)
- Job Description The Director , Regulatory Affairs Oncology, is responsible for development and implementation of worldwide regulatory strategy for their ... functions with a high degree of independence and provides regulatory oversight for assigned products, in order to optimize...include, but are not limited to: * Reports to Director , Executive Director or Associate VP Oncology… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to take charge of your future at Takeda.A' Join us as an Associate Director , Regulatory Project Manager in our Cambridge office.A' Here, everyone matters and ... vital contributor to our inspiring, bold mission. As an Associate Director on the Regulatory Project Management and Strategic Planning team, you will be… more
- Intellia Therapeutics (Cambridge, MA)
- …infections, inflammatory disorders and many more. Summary: Reporting to the Vice President, Regulatory Affairs and Quality, the (Sr) Director of Regulatory ... Strategy will be responsible for the development and submission of regulatory filings for CRISPR/Cas9 based gene therapy projects, in the US and internationally. The… more
