- Rhythm Pharmaceuticals (Boston, MA)
- …and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ensuring ... cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs. Responsibilities and Duties...degree in life sciences preferred + 8+ years of Regulatory Affairs experience in drug development and… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... and registration strategies within the US and Canada. The Director will also provide line management, people development, and...Health Canada as needed for all aspects pertaining to drug development including resolution of key regulatory … more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Director , Regulatory Affairs will be responsible for developing and implementing global ... drug -device combination products preferred. + Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing… more
- Fujifilm (Research Triangle Park, NC)
- **Position Overview** The Director , Regulatory Affairs is a pivotal role providing regulatory expertise and leadership to the FUJIFILM Biotechnologies North ... and procedures, offering strategic direction throughout the organization. Additionally, the Director leads a team of regulatory specialists through fostering… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory ... Externally, the individual will interface with business partners regarding global development, regulatory , and registration strategies. + The Director , Global … more
- Lilly (Indianapolis, IN)
- …new medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will ... for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and...drug development science(s). + Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is ... drug /device clinical development and knowledgefromhealth authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of ... EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug ...and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven… more
- J&J Family of Companies (Titusville, NJ)
- …as a single submission. Johnson & Johnson Innovative Medicine R&D is recruiting for a Director , Global Regulatory Leader. This position is a hybrid role and can ... Titusville, NJ; Raritan, NJ; or Spring House, PA. The Director , Global Regulatory Leader will be responsible...is required. + A broad understanding and experience in drug development, including early and late development is required.… more
- Stryker (Flower Mound, TX)
- The ** Director , Regulatory Operations** leads regulatory compliance for the **Endoscopy Division** and provides strategic leadership to cross-functional ... ensuring timely market access for products in alignment with applicable regulations. The Director will be responsible for roughly 5 direct reports and a total team… more