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Ensure risk assessments are conducted and appropriate mitigation and treatment plans are defined for product developments, effectively liaising with business partners and customers across Technical Research and Development (TRD), Global Industrial Operations (GIO), Global Regulatory Affairs (GRA) and vaccines product development teams.
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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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Work closely with Regulatory Affairs, Analytical Development, API Process Development, Drug Product Process Development and External Stakeholders to communicate document-specific timelines to team members to ensure timely deliverables.
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Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, Regulatory CMC Dossier - Biotherapeutics based in Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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Understanding of process validation, process development, and process characterization within product life cycle management is preferred. Regulatory CMC writing experience in pharmaceutical biologics (cell and/or gene therapy a plus) is preferred.
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Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. Project leadership: independently lead CMC team meetings to resolve reviewer comments on the regulatory dossiers, execute dossier updates and meet regulatory timelines.
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Organization Janssen Research & Development, LLC (6084) Support the CMC functional subject matter experts in the development, authoring, and editing of CMC related technical data for inclusion in Modules 2 and 3 of the eCTD.
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Prepare, review, manage, and lead responses to CMC related questions from regulatory authorities. Primary Responsibilities Authors/drives sections of the CMC dossier and evaluates/ensures that final versions align with requirements and fulfill regulatory agency expectations.
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Supports the technical functions in the development of responses to health authority questions related to clinical trials and marketing applications. Evaluates and ensures the completeness, accuracy, and compliance of data for all regulatory submissions.
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Proven understanding of regulatory requirements for complex biologic products, as well as experience authoring IND and BLA filings is preferred. Job Function Regulatory Science. Lead and execute CMC writing for clinical (CTA, IND) and marketing applications (BLA, MAA) for biologics.
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Demonstrates advanced knowledge of regulatory requirements (including those related to IVDs, notably IVDR) and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives.
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With general guidance from the Senior Director, Regulatory Affairs and Corporate Stewardship, the Regulatory Affairs Manager will lead the Association’s policy agenda and coordinate regulatory and legislative priorities in the areas of infrastructure and environment, health & safety (EHS.
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Responsible for development, implementation and maintenance of the company’s global regulatory affairs department and strategy. This position will be responsible for spearheading all regulatory compliance and safety reviews of the brand’s new product development launch calendar in addition to maintaining compliancy of the existing product portfolio.
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Internally, the role collaborates closely with other members of the Scientific Affairs teams as well as product marketing, development, and field representatives. ATEC’s Scientific Affairs team is responsible for regulatory, testing, and research activities in support of the company’s initiatives.
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Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
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regulatory affairs product development jobs Title: regulatory affairs manager Company: Nemera France Sas
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