Associate Director, Regulatory Affairs-CMC

Company Overview
This company is focused on developing and delivering life-transforming therapies for patients with devastating rare diseases.

Job Description
The Associate Director of Regulatory Affairs-Chemistry, Manufacturing, and Controls (RA-CMC) in Japan will be responsible for leading and providing Japan CMC regulatory support for the clinical and commercial product portfolio, which means managing of filing the highly strategic documents of the quality part of the new drug application and change control application of our approved drugs, proceeding discussion with the Japanese Authorities by using technical regulatory expertise of CMC to develop and maintain the drugs in the Japanese market. The duty includes collaborating with the global CMC/RA team, managing the team member of Japanese CMC regulatory, selecting and managing external contractors and proposing an appropriate budget plan for the successful CMC regulatory activities. Also, the Associate Director will be responsible for maintaining local GMP organization and the quality of GMP documentations. Furthermore, the Associate Director will support staff capability improvement.

Principal Responsibilities
Provide CMC support and advice for all internal activities related to manufacturing, development, control, and quality of commercial and clinical products.
• Independently lead, plan and manage assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including Life Cycle Teams and compliance of clinical and commercial products.
• Lead the development, preparation and submission of the CMC dossiers, supplements, and renewals for commercial products.
• Define and lead the development of high quality regulatory submissions.
• Manage, track, and assure accountability to Japanese regulatory CMC commitments.
• Develop proactive regulatory strategies for Japan CMC product lifecycle management, with limited oversight. Independently resolve complex issues and manage regulatory risks and ambiguous situations within project teams. Investigates opportunities for regulatory innovation / promote the use of novel approaches and present CMC strategies and plans to management and appropriate core teams.
• Prepare teams for pre-submission meetings with Japanese Authorities (MHLW: Ministry of Health, Labor and Welfare; PMDA: Pharmaceuticals and Medical Devices Agency) to reach agreement on complex CMC requirements. Interfaces directly with Japanese Authorities in order to discuss and define regulatory applications (Quality Module, Responses, and Commitments). May act as CMC representative in formal meetings and teleconferences with Japanese Authorities.
• Partner with representatives of Regulatory Affairs including Japanese regulatory leads, Manufacturing, Technical Services, Process Development, Quality and other key partners both internal and external to the company. Provide guidance and expertise on assigned RA-CMC documents/projects. Participate in GMP inspections and lead RA-CMC interactions.
• Partner with Manufacturing, Quality, Technical/Analytical Development and Research to develop the CMC CTD content and ensure compliance with Japanese requirements in preparation for licensure.
• Propose new/revised policies and recommend standard interpretation of Japanese regulations. Maintain an awareness of Japanese legislation and assess its impact on the business and product development programs.
• Mentor junior staff as needed.
• Manage local GMP organization and related activities for investigational medicinal product, and ensure the quality of GMP documentations.
• Get enagged in the Submission sub-team as a CMC lead and join the Global Regulatory Affairs sub team according to scope of discussion.

Requirements
Minimum of 10 years of industry experience with at least 6 years of Regulatory CMC experience; extensive experience should be in CMC of antibodies, protein therapeutics or other biological products. Have an experience of getting not less than 3 products as a roll of J-NDA core team member.
• Strong written and oral communication skills; comfortable communicating with and building relationships with numerous stakeholders in a cross functional environment.
• Have a broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.

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