Job DescriptionThe Director of SDRA is responsible for leading and managing regulatory activities within the Region Japan and Korea CMR organization which consists on Strategic Regulatory Affairs, Regulatory CMC, Device, Regulatory Compliance, Package Insert & Packaging (PI&P), and Regulatory Operations. Director oversights execution of regulatory strategies and product development of new medicines and devices as well as maintenance of marketing authorization (MA) for existing products in both Japan and Korea through generation of high quality documents including PI&P aligned with global regulatory strategies and dossiers, local regulatory requirements, and other external/internal guidelines.
1) Confirm high quality applications for product MA to obtain a fast approval with excellent labelling as defined in the Product Business Plan (PBP). Support projects during submission and review phases to optimise the filing and approval processes.
2) Support project teams in order to facilitate the development and to prepare the appropriate development plan in alignment with Therapeutic Product Profiles and the Key Product Claim. Be responsible for strategic regulatory input to project plans and high quality deliverables in accordance with project milestones defined in PBPs.
3) Interact effectively with regulatory authorities to obtain and maintain product MA. Support the company as drug and device MA Holders via regulatory compliance activities. Oversight planning and execution of contacts with regulatory authorities.
4) Secure resources to execute the task in SDRA and coach the staff to develop their competencies, skills, and knowledge in order to accomplish their accountabilities. Be responsible for continuous improvement of SDRA’s “way of working” in close collaboration with the company in Japan and Korea as well as Global Regulatory Affairs and International Operations and for creating enthusiastic, challenging, and results-oriented teams in SDRA.
5) Contribute to overall governance of RJK CMR organization and be responsible for results and deliverables as the regional CMR Management Team.
6) Provide regulatory and drug development expertise to decision making in projects as a member of the Development Review Committee and Regional PDP Forum. Be responsible for providing strategic and operational input to the Project Portfolio Management.
7) Develop the Department with high quality. Assure compliance with company quality system and SOPs for regulatory affairs. Conduct benchmarking of regulatory environments and sharing of good practices to secure optimal regulatory processes.
8) Plan the Department budget and appraise performance of the members. Be responsible for budget control, salary adjustments, and staff incentives.
9) Contribute to global regulatory activities as a Global Regulatory Board member and IO RA Head member. Be responsible for execution of the mandates.
Requirements- University or more degree in medical, biological or pharmaceutical science
- 10+ years experiences in Japanese regulatory affairs including knowledge of the Japanese Pharmaceutical Affairs Laws and execution of NDA filings and approval of pharmaceuticals and/or medical devices
- 15+ years of experiences in drug development
- Having broad network with regulators and industry representatives at high level position.
- Strong leadership, negotiation skills, and strategic thinking, balanced business mind, ethical behavior, open minded, proactive mind-set, prepared for changes and customer-oriented attitude
- A high level of ability to read, write and speak English and orthodox Japanese
- A high-degree of confidence building capacity
Not a must but Preferable;
- Possible DRC membership
- Pricing/reimbursement knowledge preferably required.
- Master or Doctor degree in science, medical, or pharmacology is preferable.