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Join Arkema in Wauwatosa, USA, as a Product Stewardship and Regulatory Affairs Specialist. If you are a driven individual with an interest in regulatory affairs and product stewardship, apply now.
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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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2) Business Relationship Management: • Foster close relationships with the Care Chemicals business and technology personnel, Quality Managers, as well as Global Product Stewardship & Regulatory Affairs colleagues, Trade Associations, and/or NGOs. • Develop and document business-specific PSRA objectives and strategies aligned with the overall business strategy.
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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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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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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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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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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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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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Frequent contacts Executive and Legislative branch staff and officials External associations and coalition partners AIA national volunteer leadership and staff AIA state and local components AIA Government Advocacy Committee ArchiPAC Steering Committee Qualifications Federally registered lobbyist High-level understanding of how to successfully lobby Congress and the executive branch, including no less than 4-6 years’ experience in working to advance legislative and regulatory proposals.
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Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.
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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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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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We invested in new offices, sector teams and practice groups including higher education; foundations; investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and creative services.
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SummaryThe Regulatory Affairs Specialist will reside within strategic business unit, Huber Specialty Minerals (HSM), at Huber Engineered Materials (HEM). Serve as primary contact for HSM hazard communication support and collaborate with HEM regulatory affairs for SDS/Labeling support.
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regulatory affairs jobs Company: Dow in RI, France
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