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Johnson & Johnson is recruiting for a Senior Director, CMC Regulatory Affairs Biologics - New Modalities, located in either Horsham, PA; Titusville, NJ; Raritan, NJ; or Beerse, Belgium. Learn more at Reporting to the VP CMC Regulatory Affairs (RA) Biologics, the Senior Director, CMC RA Biologics.
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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 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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The Role Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable.
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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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The Regulatory Affairs Specialist will provide regulatory support for the Catalent Cell and Gene Therapy sites. This position will evaluate facility change controls for compliance with applicable change control guidance and will maintain site master files and Type V DMFs. In addition, the Regulatory Affairs Specialist will provide audit support and assist in preparing for group meetings and communications as appropriate.
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We are seeking a driven, creative, collaborative, and highly respected individual who is passionate about public policy, government affairs, regulatory policy, helping patients, innovative science, biotechnology, and public health to serve as Vice President, Policy & Advocacy.
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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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Work closely with State & Local Government Affairs and Regulatory Affairs on multi-tiered strategy that crosses our state footprint and at the federal level. Work closely with the federal affairs and regulatory affairs and policy teams on ongoing engagement of key legislative activity, including bill analysis and tracking; attending hearings, briefings and mark ups; and general legislative monitoring.
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Maintain clear communication channels with key stakeholders and partners (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) to ensure team resources are focused on critical asset support and related initiatives.
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This role leads the Optum Legal, Compliance and Regulatory Affairs (LCRA) Executive Council and is a critical member of the UHG LCRA senior leadership team. This Executive Leadership Team (ELT) role reports to the UnitedHealth Group (UHG) Chief Legal Officer and the Optum Chief Executive Officer, provides thought and practical leadership, and is accountable for legal and regulatory affairs teams, programs, and activities across the Optum businesses.
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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.
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The UPSIDE Foods Global Scientific & Regulatory Affairs (GSRA) team is hiring an Associate Director, Regulatory Operations to proactively create and build effective regulatory compliance operational capabilities.
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regulatory affairs jobs Title: entry level Company: Vector Marketing in MT, Canada
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