Director, Global CMC Regulatory Affairs (EU) (m/f/d)

Job Responsibilities

1. 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.

2. 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.

3. 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.

4. 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.

5. Represent Otsuka at regulatory authority CMC meetings. Lead interactions and negotiations with regulatory authorities on CMC and GMP issues for products.

6. Monitor, interpret, and provide guidance on current developments in guidances, regulations, practices and policies in CMC and GMP areas.

7. Provide regulatory assessment and input on Change Controls, review supporting data and reports and update in computer systems as needed.

8. Proficiency with the tools and systems needed for the job function (Reg Intel, EQMS, EDMS, etc.).

9. Be proactive member of teams: Project, Clinical/Regulatory Teams, Global Regulatory Teams (GRTs), Submission teams and Lead CMC GRTs, and Submission CMC subteams.

10. 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.).

11. Position may have direct reports and multiple CWs to lead, manage, coach and support.

12. Demonstrates a personal understanding of Otsuka culture and is viewed as a cultural role model.

13. Assist with CMC RA administrative leadership duties including staffing, budgeting, documentation, SOPs, and communication with key internal and external stakeholders.

14. Performs other duties as assigned.

Minimum Qualifications

1. Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues.

2. 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.

3. 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.

4. 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).

5. Comprehensive understanding of the global regulatory environment.

6. Proactive strategic thinker; Operationally minded (demonstrated ability to prepare a high-quality technical document or submission using internal systems).

7. Strong analytical, problem solving, organizational and negotiation skills.

8. Strong collaborative inter-personal, communication, presentation and meeting leading skills.

9. Strong ability to work in a matrix environment and across cultural lines. Influences others outside of functional area regarding policies, practices and procedures.

10. Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).

11. 9 to 12 years CMC regulatory experience in the pharmaceutical industry with a history of successful investigational filings and approvals of marketing applications as the CMC Regulatory lead.

12. Similar knowledge of Asia-Pacific, Latin America and middle-east countries will be a plus.

13. 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.

14. As a CMC Quality reviewer (assessor) with FDA or EMA is highly desirable.

15. Bachelors degree in Pharmaceutical Sciences or Chemistry or Pharm.D.

16. Masters degree or Ph.D. preferably majoring in Pharmaceutics or Industrial Pharmacy and minor in Organic Chemistry or vice-versa.

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