- Bausch Health (Bothell, WA)
- …Health Canada registration, CE Marking, global product registrations, and clinical evaluations/studies Regulatory affairs professionals responsible ... Manager, Regulatory Affairs Medical Device-Aesthetics (Bothell, WA) 1 of 2 Job Location: Bothell, Washington, USA Job Requisition ID: 13600 Join our global… more
- Olema Oncology (San Francisco, CA)
- …effectively manage end-to-end label implementation. This role will work closely internally with Regulatory Affairs , Clinical Development, Clinical Supply ... research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical Proven 3-5… more
- Merck & Co. (Rahway, NJ)
- …, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... and effective implementation and oversight model to maintain best in industry regulatory compliance.The Vice President Regulatory Affairs , General Medicine… more
- Elanco Animal Health Incorporated (Indianapolis, IN)
- …and products. Proactively participate in global, cross-functional project teams (eg, clinical , pharmaceutical development, regulatory affairs , quality, ... life better - join our team today! Your Role: Senior Research Scientist, Non- Clinical Safety & Toxicology We are seeking an experienced non- clinical toxicology… more
- Dyne Therapeutics (Waltham, MA)
- …objectives. The successful candidate will collaborate with cross-functional teams, including regulatory affairs , clinical operations, biostatistics, and ... optimize the effectiveness of their time Coordinate cross-functional collaborations between Clinical Development, Regulatory Affairs , Commercial, and other… more
- Lifelancer (London, KY)
- …and global regulatory interactions. Cross-Functional Collaboration Partner closely with Clinical Operations, Regulatory Affairs , Program Management, CMC, ... medical affairs teams. Demonstrated track record in leading global clinical trials and progressing programs through regulatory milestones. Deep understanding… more
- MEITHEAL PHARMACEUTICALS INC (Chicago, IL)
- …scientific communications on Meitheal therapies. Engage with internal departments (eg, Clinical Development, Regulatory Affairs , Commercial, Market Access) ... including GPP (Good Publication Practice) and ICMJE standards. Collaborate with clinical , regulatory , and medical affairs team members to ensure publications… more
- Alkermes (Waltham, MA)
- … submissions. Collaborate cross-functionally with Biostatistics, Clinical Operations, Clinical Research, Regulatory Affairs , and other functions ... In addition to hands-on writing, this role provides strategic input into clinical development and regulatory submissions, leads process improvements within… more
- Barrington James (Madison, OH)
- …CSRs, and regulatory filings. Cross-Functional Collaboration Work closely with Clinical Operations, Regulatory Affairs , Safety, Program Management, and ... will focus on the medical and scientific oversight of clinical trials from design to regulatory submission....oversight of clinical trials from design to regulatory submission. The ideal candidate will bring strong cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- BridgeBio Pharma (Palo Alto, CA)
- …external stakeholders and Cross-functionally with Market Access, Commercial Operations, Marketing, Clinical Development, Regulatory Affairs and Strategic ... of new drugs or therapies Collaboration: Working with cross-functional teams, including clinical development, market access, and medical affairs , to understand… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution of Global ... Medical Affairs /MSL training and continued education plans related to Eisai's...regional medical directors and MSL leadership, Publications, Medical Communications, Clinical Development, Biostatistics, Field HEOR, Patient Advocacy, and other… more
- ADC Therapeutics SA (New Providence, NJ)
- …for biotech and pharma) *The ideal candidate would have experience and/or exposure to clinical development, regulatory affairs and technical operations of a ... skills advantageous. *Proficient with a wide range of data/information: scientific/ clinical , legal/ regulatory , business, financial and market analytics. *Mindset… more
- Boston Scientific (Maple Grove, MN)
- …pipeline, and we will continue to make an investment in Interventional treatments. This Regulatory Affairs Specialist II role will be a part of the ... Interventional Cardiology Regulatory Affairs...discipline within the medical device industry (eg, R&D, Quality, Clinical , Medical Affairs , Biocompatibility) Introductory knowledge of… more
- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out ... As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support...regulatory review. Monitor and submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical and… more
- Abbott (Minneapolis, MN)
- …people to restore their health and get on with their lives. The Opportunity The Regulatory Affairs Manager will work on-site at our Plymouth, MN location for our ... division. As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of...regulatory submission to authorities. Evaluate risk of and regulatory solutions to product and clinical safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at our Alameda, ... in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine knowledge of scientific, … more
- Boston Scientific (Maple Grove, MN)
- …required Required qualifications: Minimum of a Bachelor's Degree 7+ years of experience in Regulatory Affairs , or 5+ years of experience with an advanced degree ... and labeling reviews of supporting documents for inclusion in regulatory filings Review of clinical study protocols and other clinical documentation, and… more
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