Director, Global Cmc Regulatory Affairs

Vor 4 Tagen

Frankfurt am Main, Deutschland Otsuka Pharma GmbH Vollzeit

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
- Problems and issues faced are difficult and may require understanding of broader set of issues and in depth knowledge and skills within the CMC RA discipline. Viewed as a principal expert and organizational thought leader
- Prepare and/or review all CMC and GMP related documents/labels and labelling 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
- Influence others outside of own job area regarding policies, practices and procedures. Develops and maintains 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
- 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 subteams
- Role may involve participation in or leading in complex projects or programs of strategic importance, involving cross-functional teams such as early stage MSRD programs, due diligence, in licensing activities across a range of drug modalities (e.g. small molecules, peptides, oligos, proteins, etc.)
- Position may have direct reports and multiple CWs to lead, manage, coach and support
- Demonstrates a personal understanding of Otsuka culture and is viewed as a cultural role model
- Assist with CMC RA administrative leadership duties including staffing, budgeting, documentation, SOPs, and communication with key internal and external stakeholders
- Performs other duties as assigned
- Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues
- Expert level knowledge and skills in CMC RA discipline with understanding of adjacent areas and industry practices, typically obtained through a combination of education and significant experience
- Thorough knowledge of FD&C Act, EMA & FDA quality guidelines, ICH and regional compendial requirements as well as EMA and FDA policies and practices for drugs, devices and drug-device combinations
- Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe (CTA, IMPD, MAA)
- Comprehensive understanding of the global regulatory environment
- Proactive strategic thinker; Operationally minded (demonstrated ability to prepare a high-quality technical document or submission using internal systems)
- Strong analytical, problem solving, organizational and negotiation skills
- Strong collaborative inter-personal, communication, presentation and meeting leading skills
- Strong ability to work in a matrix environment and across cultural lines. Influences others outside of functional area regarding policies, practices and procedures
- Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
- Similar knowledge of Asia-Pacific, Latin America and middle-east countries will be a plus
- 3 to 5 years of hands-on pharmaceutical product development, including scale-up and technology transfer to manufacturing and/or manufacturing experience is highly desirable
- As a CMC Quality reviewer (assessor) with FDA or EMA is highly desirable
- Bachelors degree in Pharmaceutical Sciences or Chemistry or Pharm.D.
- Masters degree or Ph.D. preferably majoring in Pharmaceutics or Industrial Pharmacy and minor in Organic Chemistry or vice-versa

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