- Insmed Incorporated (San Diego, CA)
- …Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the ... (fast track, RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs ... , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory ...and working toward building a quality mindset with Medical Affairs .Support the Sr. Director 's Medical Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... Experience: Demonstrated track record of success working on multidisciplinary, international pharmaceutical development teamsExperience with CDx regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to ... global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Director , US HEOR and RWE (field) is responsible for developing HEOR engaging population-based ... research activities and development of external communication materials. The Director facilitates coverage, reimbursement and appropriate utilization based on… more
- AbbVie (Mettawa, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , International Regulatory Affairs Advertising & ... and practices to adhere to the highest quality and regulatory standards. The Director will design and... strategy and global brand plan and leads the international regulatory strategy for the assigned marketed… more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an ... promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and...to travel to various meetings including overnight trips. Some international travel may be required. + Requires up to… more
- Actalent (St. Paul, MN)
- Director of Regulatory Affairs Structural Heart | Medical Device Relocation Offered We are seeking an experienced Director of Regulatory Affairs ... advisor to the executive team and develop a high-performing regulatory affairs team to support company objectives... assessments for reportability and submit FDA MDRs and international vigilance reports as needed for tissue-based products. +… more
- Chemours (Providence, RI)
- …living depend on Chemours chemistry. Chemours is seeking a ** Director of Regulatory Advocacy** to join our growing Government Affairs team! This position ... Group with a primary responsibility for supporting US federal regulatory affairs engagement with the United States...management and business leaders on US federal and select international regulatory issues. + Provide thought leadership… more
- Abbott (San Diego, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs ** , works out of our ... (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and economic decision-making to help… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... to prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you… more
- Boehringer Ingelheim (Athens, GA)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , US Regulatory Affairs Pharmaceuticals leads the US ... and Safety & Efficacy support in the USA and International markets for all new product types and entities...products in accordance with company priorities and governance. The Director , US Regulatory Affairs Pharmaceuticals… more
- GRAIL (Menlo Park, CA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... regulatory approval. + Monitor and report on international regulatory developments and LDT requirements that...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Stryker (Tempe, AZ)
- The ** Director , Regulatory Affairs ** is a key strategist, responsible for developing and executing the global regulatory strategy for **Stryker ... standards + Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activities… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow and become your best self. Become a **maker of possible** with us. The Sr. Director , Regulatory Affairs is the ranking Regulatory Affairs ... regulatory leadership for programs in the domestic and international space + Provides strategic guidance to ensure alignment...business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA)...overseeing product compliance and registrations at state, national, and international levels. They will monitor and influence regulatory… more
- Bristol Myers Squibb (Princeton, NJ)
- …Madison, New Jersey **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and ... background, PhD., MD, PharmD, MS **Experience Requirements:** Significant experience in regulatory affairs and diagnostic-related development eg, >8-10 years.… more
- BeOne Medicines (San Mateo, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and ... medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical … more
- Stryker (San Jose, CA)
- The **Senior Director , Regulatory Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and ... desired **Knowledge / Competencies:** + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements +… 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 ... medicines that make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing… more
