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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Reporting to the Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs - CMC will be responsible for leading, developing, and executing CMC regulatory strategies on programs ranging from early to late-stage development, including preparation and filing of IND and NDA/MAA submission.
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15+ years of pharmaceutical/biotech drug development experience with 5 + years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules.
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We are looking for an Associate Director/Director, Regulatory Affairs CMC to join our team. Minimum 8-10+ years progressive Regulatory Affairs experience; 6+ years with an advanced science-related degree.
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Requires Masters degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and six years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs, or a Bachelors degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and eight years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs.
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Establish appropriate strategic partnerships with internal leaders in clinical development, regulatory affairs, safety, operations, research, and commercial. Collaborate with legal, compliance, and regulatory authorities to ensure proper and ethical interactions between medical affairs personnel and external stakeholders.
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10+ years of experience in regulatory affairs in biotechnology and/or pharmaceutical industries, directly as regulatory lead and in a leadership role to deliver therapeutic(s) and diagnostic biomarker(s) in our key therapeutic areas (metabolic disease, neurology/neurodegeneration, oncology) to the clinic from FIH through proof-of-concept to NDA/BLA submission.
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Requirements:Advanced degree in life sciences in one or more of the following: MD, DO, PharmD, PhD, and 2+ years of relevant Medical Affairs (medical device/pharmaceutical industry), managed care, and HEOR experience, required.
$191,335 - $247,610Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Advise internal cross-functional team who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, & others such as Commercial.
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The City of Burlingame is currently recruiting for a self-motivated, highly organized individual with a proven track record of successful independent judgment to join our Department of Public Works as the Environmental Regulatory Compliance Manager.
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Extensive experience in late phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China. Thorough understanding and working experience of pharmaceutical drug product with respect to GMP, quality systems, ICH guidelines, FDA, EMA and associated regulatory requirements.
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Senior Regulatory Affairs Specialist, Redwood City, CA - Develop strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate approval with global regulatory agencies.
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Collaborate with cross-functional teams, including medical affairs, regulatory affairs, biostatistics, and data management, to drive clinical development activities and achieve milestones.
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The Sr. SMA/SMA will also work cross-functionally with other groups such as Clinical Development, CMC/Supply Chain, Regulatory Affairs and Project Management. Knowledge of FDA regulatory requirements and ICH/GCP guidelines.
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Pharmaceutical product development, product lifecycle, and commercialization process knowledge with an understanding of other functions, including but not limited to HEOR, value & access, safety, and regulatory.
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regulatory affairs jobs Title: regulatory specialist Company: Abbvie in San Mateo, CA
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