- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape. + Understanding of other relevant regional … more
- Boehringer Ingelheim (St. Joseph, MO)
- …as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety &...technical input for Freedom of Information Summary and product labeling for assigned projects. + Works in project teams… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Director Regulatory Affairs , Advertising and Promotion will be an ... the promotion of prescription drug and biologic products. The Director Regulatory Affairs , Advertising and... impact of new campaign concepts, target, or product labeling , and providing strategic regulatory guidance on… more
- Bristol Myers Squibb (Madison, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs ** **Description** : The ... role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply...and subpart E and H submissions + Ensure full regulatory compliance of all promotions with approved labeling… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow and become your best self. Become a **maker of possible** with us. Director of Regulatory Affairs is responsible for developing and implementing ... Director , Regulatory Management, WW IPD ("Sr Director Regulatory WWIPD") and submissions, in support...with US and international laws and regulations + Manage Regulatory Affairs platform and leads a team… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Sarasota, FL)
- Hiring Company: Delicatessen Services Co., LLC Overview:The Director of Regulatory Affairs provides strategic leadership and oversight for all food safety ... labeling , claims, and manufacturing processes adhere to applicable food safety and regulatory requirements. The Director will serve as the primary liaison… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling strategy… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ... critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs -...maintained. + Provides input into the global organization for labeling strategies of marketed drugs. + Demonstrates significant autonomy… more
- Sumitomo Pharma (Lincoln, NE)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- Amgen (Washington, DC)
- …do your best work alongside other innovative, driven professionals in this meaningful role. ** Regulatory Affairs Senior Director - Global Regulatory ... vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and become your best self. Become a **maker of possible** with us. **The Associate Director of Regulatory Affairs ** will provide regulatory support for ... regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling existing product registrations including… more
- The Hershey Company (Hershey, PA)
- …location is Hershey or east coast with travel to Hershey monthly.* * Overview* The Director of Regulatory Affairs for the Americas is responsible to assure ... including but, not limited to auditing and monitoring, and regulatory approval processes. The Director will proactively...issues impactful to the business. 3. Lead the cross-functional Regulatory & Scientific Affairs team to continuously… more
- GRAIL (Albany, NY)
- …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 ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... issues and to expedite approvals of product and labeling changes + Maintains awareness of global regulatory...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- Boehringer Ingelheim (Ridgefield, CT)
- …field with eight to ten (8-10) years' experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required OR Master's degree with a ... Boehringer Ingelheim's high regard for our employees. The Associate Director , DRA Product Labeling will lead and...six (6) years' experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required. +… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …for new products. Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and local … more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the ... Preferred **Knowledge and skills** + Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required + Solid… more
- Evident Scientific (Needham, MA)
- …supporting submissions, inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs - Clinical Business, the ... Sr. Mgr., Regulatory Affairs (RA) & Clinical ...clinical evidence synthesis. + Ensure alignment between clinical data, labeling , and regulatory claims. **Post-Market Compliance &… more
- Kelly Services (Dallas, NC)
- …The Regulatory Affairs Associate supports the Quality Assurance & Regulatory Affairs Director in ensuring company-wide compliance with regulatory ... Affairs Associate** **Location:** Dallas, NC **Department:** Quality Assurance & Regulatory Affairs **Reports To:** Director , Quality Assurance & … more
- Chiesi (Cary, NC)
- …consisting of cross-functional medical colleagues including provides medical input on US labeling and regulatory interactions + Ensures timely and appropriate ... of this role is to lead the PAH/PH-ILD US Medical Affairs team, ensuring alignment with Global Medical Affairs to execute the medical operating plan and Medical … more
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