- Actalent (Boston, MA)
- Position: Director /Sr. Director of Regulatory CMC Location: Charlestown, MA About the Role We are seeking a creative and agile regulatory ... professional to join our collaborative team as the Director /Sr. Director of Regulatory CMC . This pivotal role involves providing leadership for our… more
- Actalent (Boston, MA)
- Key Duties & Accountabilities: * Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary teams (eg CMC Teams, ... to agency questions, and maintenance activities. * Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams… more
- Astellas Pharma (Westborough, MA)
- …and/or credibility. **Organizational Context:** Reports to Director or Senior Director , Regulatory Affairs CMC . **Qualifications:** **Required** + BS ... Pharmaceutical Technology, Quality Assurance, Business Partners). Responsible for developing global CMC regulatory strategy (eg, CMC strategy/planning for… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- AbbVie (Boston, MA)
- …improvements, and drug substance tech transfers. Responsibilities: + Lead cross-functional CMC team(s) in authoring sections of regulatory documents, including ... + Drive alignment with key business stakeholders including Development Sciences, Quality Assurance, Regulatory Affairs and others at the Director and VP level +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives on drug-device ... product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC ; international experience is a plus + Experience working… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …regulatory affairs + Has knowledge of fundamental understanding in Clinical Sciences, Regulatory CMC , DMPK, Pharmacology and Toxicology + Has ability to ... accountable for ensuring that stakeholders (including executives) are aligned; that regulatory agencies understand Takeda's CMC strategies through active… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Pharmaceutical Sciences Program Leadership where you will be responsible for ... Sciences Early-Stage Portfolio team, you will report to Pharmaceutical Sciences ( CMC ) Early-Stage Portfolio Leader and mentor and cultivate best practices in… more
- Takeda Pharmaceuticals (Boston, MA)
- …industry experience including significant experience in analytical science, cGMP compliance, CMC regulatory requirements in multiple analytical development areas ... regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Develop, implement and execute a smart… more
- Sanofi Group (Cambridge, MA)
- …an **Analytical Development Director ** to lead the analytical group in our CMC function at Cambridge Crossing site, which is part of the synthetic platform ... **Job Title:** Analytical Development Director + **Location:** Cambridge, MA **About the Job**...within Global CMC Development. We are striving to become an industry… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …global pharmaceutical/ biotechnological drug development and proven knowledge of the global regulatory CMC environment + Extensive experience in authoring and ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Reg Affairs Device, PDT in our Global..., Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device organization in… more
- Sanofi Group (Waltham, MA)
- **Job title: Director Non-clinical Biostatistics - Vaccines** + Location: Swiftwater, PA or Waltham, MA (must have ability to work onsite 2-3 days per week per ... Join our Translational and Nonclinical Biostatistics team in Sanofi Vaccines as the ** Director of Non-clinical Biostatistics** where you will lead a team of experts… more
- Takeda Pharmaceuticals (Boston, MA)
- …and scientists in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. **ACCOUNTABILITIES:** +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
- Bristol Myers Squibb (Devens, MA)
- …interpretation of regulations as they apply to Cell Therapy . + Experience with regulatory inspections and CMC + Experience with Quality Management System. + ... lives. Read more: careers.bms.com/working-with-us . **Title: Sr. Manager / Associate Director , Global Sterility Assurance CTTO** **Location: Seattle, WA, Devens, MA… more
- Takeda Pharmaceuticals (Lexington, MA)
- …BLA/MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Represents AD and provide ... of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual will… more
- Frontier Medicines (Boston, MA)
- …scale-up challenges + In collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to support all development ... candidates + .Work collaboratively with Quality Assurance and Regulatory to review analytical documents, stability results, manufacturing batch records and … 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 (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... and transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about… more