- Ironwood Pharmaceuticals (Boston, MA)
- …burden of GI diseases and address significant unmet needs. Position Summary: Lead the Regulatory Affairs CMC function supporting process development and the ... gain alignment on requirements and advance filings. Major Responsibilities: Lead the Regulatory Affairs - CMC function and set the long-term regulatory … more
- Ironwood Pharmaceuticals, Inc. (Boston, MA)
- …You join a community of innovators working together to meet the significant needs of patients with GI diseases. You'll become part of a team that celebrates the ... unique attributes and viewpoints of each individual and encourages ownership of decision-making to shape the future by challenging what has been done before.We strive to support and empower every Ironwoodian, providing opportunities to collaborate with… more
- Adverum Biotechnologies (Redwood City, CA)
- The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum's gene therapy program/s. This individual will be the key ... regulatory , and registration strategies. What you'll do:Manage the Regulatory Affairs ( CMC ) Strategy for... plans and strategiesProactively partners and aligns with the SVP/ Head of Regulatory on the development of… more
- Orca Bio (Menlo Park, CA)
- …blood and immune systems with healthy ones, but also restore their lives.The (Sr.) VP/ Head of Regulatory Affairs will lead the company's regulatory ... regulatory plans for Orca Bio's product pipeline. The SVP/ Head of Regulatory will provide oversight of...ensure alignment and timely feedback.Build, mentor, and lead the Regulatory Affairs team, ensuring team members are… more
- Scismic (Boston, MA)
- …and developing novel medicines for cancer.We are seeking an Associate Director/Director of Regulatory Affairs to join the company. This candidate will be first ... Sciences, Pharmacy or related field is required; Advanced degree or certificate in regulatory affairs is preferredMinimum of 6 years of direct regulatory… more
- Dennis Partners (Boston, MA)
- …is an exciting time to join this growing organization!Responsibilities:Build and lead the Regulatory Affairs function to ensure adherence to regulatory ... for all clinical development programs.In close partnership with the Head of QA, as needed, oversee GMP, GLP and...used to support the clinical development programs.Build a strong Regulatory Affairs and Quality team to meet… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Manufacturing (PDM) Project teams. The role will report directly to Head of CMC Regulatory Affairs - Biologics at Gilead. **Specific Responsibilities and ... headquarters in Foster City, California. **About the Role:** The Senior Director, CMC Regulatory Affairs for Biologics is responsible for leading a matrix… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs CMC team, you will report to the Executive Director and Head , CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + ... Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence changing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. **JOB** ... to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks. + Demonstrates success in influencing without… more
- Amicus Therapeutics (Marlow, OK)
- …with regulatory requirements and company standards. . Work closely with Regulatory Affairs and Technical Operations teams to ensure alignment and compliance ... Executive Director, Head of Quality Operations Location Marlow, UK Requisition...External Partners. . Facilitate or host GMP inspections by regulatory authorities and maintain a state of inspection readiness.… more
- AbbVie (Cambridge, MA)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head , GRS, is responsible for ... the management of global regulatory leads with product and disease state expertise for...+ Strong experience working with multiple functions (Ad/Promo, Labeling, CMC , devices, Clinical development, etc.) and cross functional teams… more
- Takeda Pharmaceuticals (Lexington, MA)
- …with colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC - regulatory Affairs , while serving as an important point ... in development and/or manufacturing. + Experience in the GMP environment, and regulatory affairs . + Experience managing technical capabilities in a global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs , Quality Control and Manufacturing Operations ... according to the analytical control strategy and data collection for regulatory submissions to support small molecule candidate progression from discovery to… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …independently, as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC /Formulations, Biostatistics, Legal, ... asset strategy, working closely with other functional areas such as commercial, regulatory , pharmacovigilance, CMC , and pre-clinical development in this regard.… more
