- Lilly (Indianapolis, IN)
- …people who are determined to make life better for people around the world. **Senior Advisor/ Director , Global Regulatory Affairs - CMC, Small Molecules** ... who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage CMC technical knowledge… more
- Boehringer Ingelheim (Ridgefield, CT)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , Global Regulatory Affairs Analytics and ... Performance is dedicated to strategically aligning Global Regulatory Affairs (GRA) objectives for all functions with quantifiable performance indicators,… more
- System One (Deland, FL)
- Position: CONTRACTOR -- Director , US Regulatory Affairs & Global Development Projects (GDP) Location: Remote (East or Central Time Zone) / Prefers local ... - 95/hr Purpose and Scope of Position The Director , US Regulatory Affairs & Global Development Projects (GDP) is responsible for providing strategic… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Lilly (Indianapolis, IN)
- …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... knowledge of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug product manufacturing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Teva Pharmaceuticals (West Chester, PA)
- …making a difference, and new people to make a difference with. **The opportunity** The Director , Global Regulatory Affairs , is a strategic role that ... Director , Regulatory Affairs , Strategy... Director , Regulatory Affairs , Strategy - Innovative Medicine...your day** + Responsible for ensuring timely development of regulatory strategies through a global regulatory… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs , Strategic Global Labeling - Combination Products ... Global industry trends and best practices in combination product and device regulatory affairs , review and comment on changing regulation and guidance. +… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs , Strategic Global Labeling, combines the knowledge ... regulatory labeling environment. + Under the direction of the Director , Global Labeling, provides regulatory leadership and expertise to licensing… more
- Bausch Health (Bothell, WA)
- …and effective aesthetic care options to consumers and physicians alike. Reporting to the Sr. Director , Global Regulatory Affairs , the Senior Manager, ... for their globally distributed products. This role is not a regional regulatory but global regulatory position which under the organization of Solta Medical… more
- Amgen (Washington, DC)
- … Affairs Senior Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory ... Regulatory Affairs organization. The purpose of the Global Regulatory Affairs Senior Director is: + To lead GRTs within Amgen's GRAAS organization… more
- Lilly (Indianapolis, IN)
- …around the world. **Purpose** : The purpose of the Sr. Director role in Global Regulatory Affairs (GRA) - Drug Delivery and Digital Health provides ... trials and market clearance/registrations. It is necessary for the Director to develop collegial and mutually productive relationships across...and regulatory expertise and lessons learned across Global Regulatory Affairs to drive… more
- Lundbeck (Deerfield, IL)
- …candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling, oversees the process and ... Director US Regulatory Global ... Director US Regulatory Global Strategic Labelling - Remote...development programs. + Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling… more
- Lundbeck (Deerfield, IL)
- …in the greater United States, preferably East Coast or Midwest **SUMMARY:** The Senior Director , Regulatory Affairs Global Strategic Labelling, oversees ... Senior Director US Regulatory Global ...Senior Director US Regulatory Global Strategic Labeling - Remote...industry, with 10+ years' experience in Regulatory Affairs . + 5+ Years experience developing global … more
- Sanofi Group (Cambridge, MA)
- …the advertising and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of ... About the Role The Associate Director , US Regulatory Affairs ...Consults with senior management and provides input to the global organization as needed. + Contributes US RA AdPromo… more
- Sanofi Group (Bridgewater, NJ)
- …and Capabilities** + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for ... The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development ... products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in...Affairs will stay abreast of changes in the global /US/Canadian regulatory framework, analyze proposed legislation/guidance that… more
- Boehringer Ingelheim (St. Joseph, MO)
- …programs reflect Boehringer Ingelheim's high regard for our employees. As the Manager/Associate Director , Regulatory Affairs Pharma Safety & Efficacy you ... of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate...will: Act as Regulatory Affairs (RA) team member in projects… more
- ThermoFisher Scientific (Wilmington, NC)
- …depend on - now and in the future. **Discover Impactful Work:** The Senior Director , Regulatory Affairs Functional Lead, FSP, provides strategic direction, ... the role. _** **Knowledge, Skills, Abilities** + Excellent understanding of global /regional/national country requirements and regulatory affairs procedures… more
- J&J Family of Companies (Irvine, CA)
- Associate Director , Regulatory Affairs (Cerenovus) - Medical Device Business Services, Inc. - 2406180618W **Description** CERENOVUS, a division of Johnson & ... Johnson MedTech, is recruiting for an **Associate Director , Regulatory Affairs ** . _This...and III devices. * Provide guidance and interpretation of global regulatory requirements to help ensure efficient… more