- BeOne Medicines (Emeryville, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline ... with applicable regulatory requirements and guidelines, and consistency with approved labeling . The role also is expected to work closely with our in-house… 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 ... 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
- Lundbeck (Deerfield, IL)
- Associate Director Medical Affairs - Neurology Requisition ID: 7013 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the ... to candidates anywhere in the greater United States** **SUMMARY:** The Associate Director , Medical Affairs , Neurology serves as the internal scientific expert… more
- CSL Behring (King Of Prussia, PA)
- **The Opportunity** As the Senior Director , Medical Affairs , you will lead the development and execution of Medical Affairs strategies and tactics to support ... + Review and approve medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs...the assigned disease area. + Provide input on US labeling and regulatory strategy. + Maintain in-depth… more
- Coty (Morris Plains, NJ)
- …part of the global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR...retailers. + Provide guidance to Product Development regarding OTC labeling and claims. Including working with the global artwork… more
- CSL Behring (King Of Prussia, PA)
- …**Qualifications & Experience Requirements** Bachelor's degree required. -8+ years of Regulatory Affairs experience, with at least 6+ years specifically ... days a week. You will report to the Executive Director , Head, Global Labeling & Labeling...and Promotion is responsible for developing and overseeing the regulatory strategy and compliance of promotional and non-promotional with… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...to the authoring of modules 2.7.3, 2.7.4, 2.5 and labeling for regulatory submissions, contribute the authoring… more
- Alameda Health System (Oakland, CA)
- …Imaging in interdepartmental initiatives involving IT, Quality, Education, Compliance, and Regulatory Affairs . **DUTIES & ESSENTIAL JOB FUNCTIONS:** NOTE: The ... strategic oversight of department-wide education, clinical competencies, quality assurance, regulatory compliance, PACS/RIS workflow support, and radiologic student training… more
- J&J Family of Companies (Raritan, NJ)
- …looking for a dynamic and visionary leader to join our Cross-Regional Regulatory Affairs team as ** Director , Labeling Science and Technology Leader** . ... be considered as a single submission. ** Director , Labeling Science and Technology Leader - Cross-Regional Regulatory Affairs ** Are you ready to shape the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ridgefield, CT location* For assigned development projects and US marketed products, the Director , US Product Group Regulatory Affairs will provide expert ... and represent US RA on US cross-functional teams. The Director , US Product Group Regulatory Affairs...including formal meetings, FDA review of registration packages, and labeling negotiations. + Establishes and implements US regulatory… more
- 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)
- …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... impact of new campaign concepts, target, or product labeling , and providing strategic regulatory guidance on… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …we can continue making a positive impact in the cancer field. The Associate Director , Regulatory Affairs , Advertising and Promotion is responsible for ... Associate Director will report to a Senior Director in Regulatory Affairs , Advertising...regulatory impact of new campaign concepts and product labeling and may also be desired to provide strategic… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As an Associate Director , Global Regulatory Affairs , you will act as the ... authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and...or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. Position will be filled… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... conversion to OTC or OTC Monograph direct including any labeling reviews and updates. + Ensure all manufacturing, packaging,...industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be… more
- University of Colorado (Aurora, CO)
- **Program Director of Regulatory Affairs ** **Description** **University of Colorado Anschutz Medical Campus** **Department: Medicine - ClinImmune - The ... Center for Clinical Immunology** **Job Title: Program Director of Regulatory Affairs ** **Position...relates to HLA testing and cellular therapy product processing, labeling , storage, and preparation for infusion. + Ability to… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… 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
- 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
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