- Novo Nordisk Inc. (Plainsboro, NJ)
- …required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout ... and PromotionGain understanding of how prescription drug clinical studies, regulatory strategy, and FDA-approved labeling affect promotion and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is Home Office ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Hinge-Health (San Francisco, CA)
- About the RoleIn this role as a Regulatory Affairs Specialist, you will have responsibility for developing and influencing regulatory policy and determining and ... pursuing courses of action necessary to obtain and expand regulatory approval of Hinge Health's medical device portfolio. This Specialist will work with internal and… more
- Helen of Troy (Boston, MA)
- …our Beauty and Wellness Team at Helen of Troy as our Director of Product Manager , Liquids (hybrid work onsite and from home), and make an immediate impact on our ... formula contains all activities needed to make the claims.Work with legal and regulatory on crafting robust clinical testing plans, driving the completion of all… more
- Conference of State Bank Supervisors (Washington, DC)
- …also demonstrating our values to reinforce a positive and collaborative CSBS culture.People Manager - At CSBS, people managers lead and engage staff to maximize ... of sensitive data as well as practices for information labeling , handling, and storage.Personnel security, including role-appropriate pre-employment background… more
- Boehringer Ingelheim (Ridgefield, CT)
- …products and products in development * Provide analysis, advice and guidance on US regulatory labeling topics with a focus on package labeling compliance ... and new development * Research information on regulatory labeling standards and departmental policies. **Requirements** * Doctor of Pharmacy degree from an… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Under supervision, the Fellow will: * Provide analysis, advice and guidance on US regulatory labeling strategies. * Research information on regulatory ... Regulatory Expertise: The Fellow will develop basic regulatory labeling expertise/knowledge in one or more...supplements initiated by BI, in conjunction with RA Product Labeling Management and the assigned RA Product Manager… more
- Gilead Sciences, Inc. (Foster City, CA)
- …project lead or lead representative from Labeling Operations. + Ensures that labeling in development is in accordance with regulatory , market, industry, and ... corporate style guidelines. + Targets the timing of labeling implementation while coordinating the approvals between Regulatory , Quality Assurance, Marketing,… more
- Danaher Corporation (Fargo, ND)
- … Manager , Operational QA, responsible for Developing and implementing labeling processes and procedures and collaborating with cross-functional teams, including ... Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align with regulatory requirements and company branding. In this role, you… more
- Medtronic (Northridge, CA)
- …that labeling , art, film, and plate proofs meet all medical, legal, and regulatory requirements. + Monitors changes in labeling regulations in the US and ... Works with the project Packaging Engineer to create and release labeling components interfacing with product development teams, manufacturing sites, regulatory… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …components, randomization file and label text). + Generates internal packaging and labeling production orders in accordance with the clinical trial design and all ... relevant regulatory requirements for assigned projects. Responsible for the creation...teams in various areas. + Manage external packaging and labeling activities + Identifies opportunities for improving business processes… more
- System One (Lakewood, CO)
- Title: Senior Content Developer-Product Labeling Instructions Location: Remote Schedule: M-F 8:00 AM-5:00 PM Pay: $79,200-$99,000 - Target Bonus on Base: 7%, ... position of Senior Content Developer who will create comprehensive instructional labeling for cutting-edge medical devices for clinical and commercial products.… more
- Chiesi (Cary, NC)
- Ad Promo Manager , Americas Regulatory Affairs, Rare Diseases Date: Sep 5, 2024 Department: GRD Regulatory Affairs Job Type: Direct Employee Team: R&D, ... and changes to existing labeling , and submission of labeling information to regulatory authorities in the United States and Canada. **Main Responsibilities**… more
- Primal Pet Group (Fairfield, CA)
- Overview We are seeking an International Export and Regulatory Affairs Manager to join Primal and own product compliance, food safety and international ... food products. Key Responsibilities + Point of contact to provide regulatory and labeling compliance expertise for developing new markets and distributors in… more
- Kelly Services (Orange, CA)
- ** Regulatory and Compliance Manager ** Kelly(R) Science & Clinical is seeking a Regulatory and Compliance Specialist for a direct-hire position at a ... field. + Minimum of 5 years of experience in food and dietary supplement labeling , regulatory affairs, or similar roles. + Strong knowledge of food labeling … more
- Boehringer Ingelheim (Ridgefield, CT)
- …. Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications. Review scientific exchange communications ... to five (3-5) years of experience in the pharmaceutical industry with experience in Regulatory Affairs. + Manager level: must have (1-3) years of experience in… more
- Teleflex (MA)
- …writing technical files to design control and labeling reviews. The Senior Manager of Regulatory Affairs for Teleflex will lead regulatory strategies. ... Sr. Regulatory Affairs Manager - Product Management **Date:** Sep 26, 2024 **Location:** Remote, MA, US **Company:** Teleflex **Expected Travel** : Up to 10%… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** Manager of Regulatory Affairs that oversees MMS Infusion products and their associated software & accessories. **Job Description** We ... **maker of possible** with us. **About the role** The Manager of Regulatory Affairs reports directly to...requirements + Support the review and approval of product labeling , promotional, and advertising materials as needed + Performs… more
