- Unilever (San Francisco, CA)
- … + Manage and track all regulatory submissions, including FDA 30-day notices for structure/function claims, product information/labels in Supplement ... THE ROLE: REGULATORY AFFAIRS MANAGER You are...business, enabling speed to market with competitive and compliant product claims. The RA Manager reports directly… more
- Lundbeck (Deerfield, IL)
- …Provides regulatory review of product documentation intended for regulatory submissions for accuracy and compliance with FDA regulations. Manages, ... Senior Manager Regulatory Strategy - Remote Opportunity...and new drug application/biologic license application for the US FDA throughout the product 's lifecycle. + Provides… more
- AbbVie (Irvine, CA)
- …Job Description The Sr Manager Regulatory Affairs represents regulatory affairs for device development and/or marketed product projects. Responsible for ... understanding of regulations for device products, leads, and participates in global regulatory product teams, interprets regulations, and provides regulatory … more
- Actalent (Cincinnati, OH)
- Quality & Regulatory Affairs Manager Job Description The Manager of Quality and Regulatory Affairs will work directly with internal and external teams to ... regulations ( FDA Cosmetics, FDA Drugs, FDA Food, EPA, and Cleaning Product Regulations)....and registration (ie, Oregon Board of Pharmacy). + Manage product formulation, regulatory , and safety inquiries that… more
- Abbott (Santa Clara, CA)
- …results for millions of people. **What You'll Work On** We are recruiting for a SENIOR MANAGER REGULATORY AFFAIRS to join the Regulatory team at the Santa ... role, you be responsible for coordinating, planning, preparation, assembly, and review of regulatory strategies and submissions to the FDA , Notified Bodies, and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …by BI, in conjunction with RA Product Labeling Management and the assigned RA Product Manager in the RA Product Groups. All qualified applicants will ... Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US product labeling. The...Sheet (CCDS) Updates, and other ad hoc issues (eg, FDA requests for labeling changes). Draft/revise product … more
- Amgen (Los Angeles, CA)
- …line management + Develop regulatory risks and predictions of interactions with regulatory agencies + Ensure regulatory product compliance for product ... time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional ...and develop relationships with points of contact at the FDA on specific product assignment + Document… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Senior Manager , US Medical Ad/Promo Regulatory Review** **Takeda Pharmaceutical** **Lexington, MA ... PA** **About the role:** Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where...regulatory strategic oversight for at least one complex product or therapeutic area/multiple products to help ensure … more
- Kelly Services (Seattle, WA)
- Kelly(R) Science & Clinical is seeking a Manager , CMC Regulatory Affairs for a direct hire opportunity with one of our clients, a commercial-stage biotechnology ... Experts. **Salary:** $130,000-160,000/year **Workplace:** Onsite in Seattle, WA **Overview** The Manager , Regulatory Affairs (CMC) is responsible for providing … more
- Astellas Pharma (Northbrook, IL)
- ** Regulatory Affairs Advertising & Promotion, Manager ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? ... regarding planning and execution of promotional strategies. + Approves FDA 2253 submissions and advises the Regulatory ...science, and the ability to apply that knowledge to regulatory issues and product development having technical… more
- Actalent (Cincinnati, OH)
- Overview: The Manager of Quality and Regulatory Affairs will collaborate closely with both internal teams and external partners to ensure that all products meet ... includes ensuring product safety for consumers and ensuring that any regulatory claims related to human safety are accurate, tested, and substantiated. The role… more
- System One (Lakewood, CO)
- Job Title: Manager , Regulatory Affairs Location: Lakewood, CO - Hybrid Salary: $125,900 - $157,400 + 15% bonus Job Summary: The Manager , Regulatory ... Strategic Regulatory Guidance: + Develop and implement regulatory strategies for new technologies and product ... submissions to secure approvals from authorities like the FDA or Notified Bodies. + Represent the Regulatory… more
- AbbVie (North Chicago, IL)
- …compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP). ... are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Responsibilities: + Responsible for a product (s) or products… more
- Omnicell (Pittsburgh, PA)
- … Regulatory Specialist II (Quality Assurance Engineer II)** Reporting to the Manager of Product Regulatory and located at the Omnicell Cranberry ... The Quality and Regulatory Engineer will be responsible for supporting product regulatory activities. **Responsibilities:** + Maintain and track product … more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim, in conjunction with RA Product Labeling Management and the assigned RA Product Manager in the RA Product Groups. * Demonstrate proficient and ... Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US package and product ...and prepare regulatory labeling documents needed for regulatory labeling submissions. * Assist with FDA … more
- BeiGene (San Mateo, CA)
- …experience with interpretation and application to development projects and marketed product regulatory issues. + Demonstrated experience in effective ... **General Description:** + The Senior Manager , Regulatory Affairs CMC, is responsible...collaborations partners and contract manufacturers. + Manage interactions with FDA and other global regulatory authorities for… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - Digital Health Technology** will work on-site ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - Digital Health Technology**...requirements. **What You'll Work On** + Provides guidance on regulatory requirements and strategies to software product … more
- AbbVie (North Chicago, IL)
- …with regulations, company policies, procedures, & guidance in alignment with regulatory product strategy & Quality Dossier Program (QDP). Qualifications ... execution of the regulatory strategy. 7. Serve as HA liaison with FDA for routine communications in support of filings including complete & timely responses… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …completion of regulatory submissions (PMA, 510(k), IDE, Pre-submissions) to the FDA and other global regulatory agencies,ORSeven (7) years experience with ... **Job Description Summary** As Manager of RA you will be responsible for... submission development and approval from EU Notified Bodies, FDA and other global regulatory agencies +… more
- Chiesi (Cary, NC)
- Ad Promo Manager , Americas Regulatory Affairs, Global Rare Diseases Date: Nov 2, 2024 Department: GRD Regulatory Affairs Job Type: Direct Employee Team: R&D, ... Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Cary, NC, US...and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing… more
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