- 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
- 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- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Takeda Pharmaceuticals (Boston, 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)
- …in a Scientific, Pharmaceutical or Engineering Discipline. + 8+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a ... for device and drug-device combination work outsourced by the Global Regulatory Affairs CMC Device and Drug-Device Combinations to external partners + Utilizes … 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)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …ADRs and provide guidance and suggestions for program management including CMC development strategy, regulatory submission strategy, quality/analytical control ... the best of my knowledge. **Job Description** **Objective / Purpose:** + Global CMC program oversight of PS with management of all project-related analytical topics,… 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
- Curia (Hopkinton, MA)
- DIRECTOR ; DOWNSTREAM PROCESS DEVELOPMENT in HOPKINTON, MA Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology ... industries. The Director , Downstream Process Development will provide technical leadership and...down models, viral clearance study designs and author associated regulatory filing documents + Design and execute Design of… 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
- 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
- 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
- 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
- Sanofi Group (Waltham, MA)
- …pace, working with other global project team members including physicians, regulatory leaders, CMC representatives, discovery scientists, and assay development ... around the world. Sanofi is recruiting for a Deputy Director of Clinical Immunology to support a diverse and...of clinical protocols, provide scientific and technical support for regulatory communications and filings, as well as define the… more
- Merck (Boston, MA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early Drug Development… more
- Takeda Pharmaceuticals (Boston, MA)
- …that will inspire you and empower you to shine? Join us as an Executive Director , Global Program Leader (GPL) in our Cambridge office. At Takeda, we are transforming ... versatile and strong enterprise leaders + be committed to simultaneously driving regulatory approval as well as product launch and global patient access +… more
- Schrodinger (Cambridge, MA)
- …stakeholders including DMPK, translational medicine, clinical development, clinical operations, regulatory , CMC , and project management to ensure completion ... We are looking to hire a **Senior Manager/Associate Director of Clinical Pharmacology** to join us in...protocols, analysis plans, and study reports + Contribute to regulatory submissions and health authority agency interactions relevant to… more