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The Regulatory Affairs Senior Specialist I, NPD is responsible for evaluating and ensuring labeling accuracy for Cepheid’s in vitro diagnostic products. Senior Regulatory Affairs Specialist I.
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The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Regulatory Affairs Specialist.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) A solid understanding and experience in drug development including early and late development is highly preferred.
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Counsel and advise the BU in areas of product safety (including TSCA, FIFRA, FDA, OSHA Hazard Communication, Hazardous Materials Transportation), product regulatory affairs, product stewardship, and product risk management as such areas may impact the research, development, manufacture, marketing, sale, handling, transportation and advertising of the BU(s) products.
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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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This position is responsible for strategy and operations of the Norton Healthcare Pharmacy Enterprise for vendor contracting, inventory management processes, 340B compliance and optimization, and compliance with other applicable regulatory organizations and requirements.
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On-Board Scientific is hiring a Nonclinical Regulatory Document and Scientific Writer based out of either New Brunswick, Lawrenceville or Summit, NJ! Qualifications: At minimum, a Bachelor’s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs. + years of Regulatory drug development experience Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
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Reporting into the Senior Manager for Origination, the Senior Regulatory Affairs Specialist’s primary responsibilities are to support Repsol’s natural gas trading/origination teams through communication of regulatory changes affecting natural gas and electricity markets and the external advocacy for the protection and betterment of Repsol’s commercial interests.
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Work with internal leaders and their teams such as Market Access, Policy Legal, HEOR, Regulatory Affairs, Finance, and Medical Affairs to identify and assess public polices and proposals that would impact AbbVie and lead the development of government affairs strategies to mitigate or improve government proposals.
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A minimum of 6-10 years experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. The ideal candidate will have experience in chemical and environmental regulatory compliance, packaging regulations, product stewardship and industrial risk management in the medical device or manufacturing industries.
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The Deputy General Counsel (DGC) will serve as a key member of the legal leadership team, assisting the General Counsel in overseeing the company’s legal affairs. Provide expert legal advice on a wide range of matters, including corporate governance, regulatory compliance, mergers and acquisitions, intellectual property, and contract management.
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Hexcel is currently seeking a Product Safety/Regulatory Affairs Specialist for our Salt Lake City, UT, USA location. Qualifications:A relevant degree (Chemistry, Environmental Science, Health and Safety or equivalent), with 3+ years of work experience in a product regulatory affairs/stewardship.
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regulatory affairs jobs Company: Care Team
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