Regulatory Affairs Manager

The Regulatory Affairs (RA) CMC Manager for APAC independently manages all regulatory CMC aspects of assigned Kyowa Kirin projects / products. This includes Biologics, Small Molecules, and Drug/Device combinations. Has sound understanding and experience in navigating Asia Pacific (APAC) regulatory environment as well as managing interactions with APAC regulatory authorities on CMC issues. He/ She must consistently demonstrate excellent interpersonal and communication skills along with the ability to conduct risk evaluations, formulate mitigation strategies, and lead multiple critical tasks.

RESPONSIBILITIES
- Represent and lead APAC in the Regulatory CMC sub-function, especially to establish strong rapport with CMC stakeholders and influence in Regulatory CMC requirements, processes and systems.
- Provide regulatory CMC input for change control impact assessments and support change implementation strategically with APAC Regional Regulatory Leads. Representative standing member in both Global and Regional Change Review Boards.
- Together with APAC Regional Regulatory Leads and Affiliates, gather up-to-date regional regulatory CMC information from available resources such as global regulatory intelligence organization, industrial committees, conferences, and literature and provide as regulatory intelligence to the regional and regulatory CMC teams.
- Conduct regulatory CMC surveys and maintenance of regulatory CMC databases with relevant stakeholders.
- Review regulatory CMC documents for APAC region including INDs, Amendments, Annual Reports/DSURs, NDAs, DMFs, Variations, Briefing Packages, ensure dossier consistency and remediation plan if inconsistencies are identified between current registered and current manufactured.
- Handle CMC projects from RA CMC for major changes (e.g., site transfers) and collaborates with APAC Regional Regulatory Leads and Affiliates for the Regulatory CMC strategies and Regulatory CMC submission activities.
- Provide regulatory CMC support and collaborate with APAC Regional Regulatory Leads and Affiliates in the following areas:

- Regulatory CMC strategies for multiple development projects leading to NDA submission and post NDA lifecycle submissions for APAC region, with a focus on innovation, maximizing the business and patient benefit balanced with regulatory compliance.
- Regulatory CMC submission activities (planning, preparation, compilation, submission) for APAC region. Advise, collaborate, and support the APAC Regional Regulatory Leads on quality regulatory decisions, balancing the risks and benefits.
- Regulatory CMC deficiency questions and inquiries from health authorities. Collaborate with project team representatives to ensure those documents meet regulatory requirements/guidance.
- Communicate and escalate regulatory CMC risks along with mitigation strategies to project team representatives.
- Collaborate with other regional RA CMC team members to enhance global Regulatory CMC function and assumes the duties of the CMC Lead for their specific region.
- Escalate appropriate issues to Global RA CMC head

**REQUIREMENTS**:

- 5+ years in the pharmaceutical industry and 2+ relevant regulatory CMC experience, experience specific to APAC is preferred.
- Bachelor’s degree in a relevant scientific discipline. Master’s or an advanced degree (PhD, Pharm D, MD) is preferred.
- Ability to conduct critical evaluations of analytical data and set clinically relevant specifications.
- Expert knowledge of the fundamental principles of pharmaceutical drug substance/drug product CMC development.
- Up-to-date knowledge of both existing and emerging regulatory guidance and sciences related to CMC.
- Experience with authoring of all drug substance and drug product sections.
- Experience or knowledge related to submissions related to CMC for biologic product is preferable.
- Strong working knowledge of Microsoft Office required.
- Ability to proactively identify issues, develop mitigation strategies, and successfully negotiate its delivery with key stakeholders.
- Ability to advise and support regulatory colleagues as needed.
- Good communication skill among internal and external related key stakeholders