This listing was posted on Manatal ATS.
Director CMC Regulatory Affairs (UK or DE)
Location:
London, Gt Lon
Description:
Job Title: Director CMC Regulatory Affairs (UK or DE) Job Location: London, UK Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: DirectorOtsuka Pharmaceutical Europe is proud to be an equal opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all Employees. All qualified applicants will receive consideration for employment regardless of their race, colour, religion, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or any other protected status.Otsuka Pharmaceutical Europe is committed to ensuring our hiring process is accessible to everyone. Should you require any accommodation or adjustments during the application or interview process, please do not hesitate to let us know.About the job :Provide CMC regulatory expertise for investigational and marketed products to project teams.Establish CMC regulatory strategies for investigational and marketed products. Ensure Otsuka’s products are developed in compliance with global regulatory requirements and guidance primarily EU and secondarily US for smooth and timely approvals. Ensure Otsuka’s marketed products are in compliance with global regulatory and guidance requirements for primarily EU and secondarily US .Job Descriptio n:- Anticipate, develop and recommend strategies and contingency plans, provide guidance, determine regulatory and scientific/technical requirements for CMC and GMP related submissions and enquiries for drugs, devices and drug-device combinations from the health authorities.- Prepare and/or review all CMC and GMP related documents/labels and labeling for submission to regulatory authorities to assure compliance with regulatory standards and scientific/technical requirements and ensure the proper preparation and approval of these submissions- Develop and maintain collaborative relationships with OPCJ CMC RA, Factory, Quality, MSRD, partners, OPDC/OPEL Tech Ops, other internal groups and contract manufacturers, packagers, suppliers etc.- Represent Otsuka at regulatory authority CMC meetings. Lead interactions and negotiations with regulatory authorities on CMC and GMP issues for products.- Monitor, interpret, and provide guidance on current developments in guidances, regulations, practices and policies in CMC and GMP areas.- Provide regulatory assessment and input on Change Controls, review supporting data and reports and update in computer systems as needed. Also support in-licensing due diligence activities.- Ensure preparation and approval of CPPs in support of Otsuka affiliates and Partners- Proficiency with the tools and systems needed for the job function (Reg Intel, EQMS, EDMS, etc.)- Be proactive member of teams: Project, Clinical/Regulatory Teams, Global Regulatory Teams (GRTs), Submission teams and Lead CMC GRTs, and Submission CMC sub teams- Position may have direct reports to lead, manage, coach and support- Performs other duties as assigne d.We Off er:Competitive salary and comprehensive benefits packa ge.Flexible working practice and remote work opportuniti es.A collaborative and supportive work environme nt.Opportunities for professional development and growth in an inclusive and equitable workpla ce. Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.Please use the below Lifelancer link to Apply and view similar roles. https://lifelancer.com/jobs/view/55ae6c629f9e9cb220f9b8eb4a0f82a7 Apply on Lifelancer Redirecting...
Company:
Lifelancer
Posted:
November 13 on Manatal ATS
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