- 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
- 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
- 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
- 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
