Job Purpose
The Regulatory Affairs Manager will :-
- Support the Marketing Authorisation transfer activities for GRA in Asia Pacific (APAC).
- Support the APAC distributors and regulatory consultants with the assigned GRA activities for APAC.
- Support the regulatory CMC activities (and strategy as needed) for assigned product(s) in APAC.
- Support update/transfer of governance & SOPs for GRA in APAC.
- Conduct APAC knowledge and activity transfer to others assigned in GRA.
- Manage the GRA CMC regulatory strategy for a development asset(s).
- Act as CMC expert for APAC region in GRA.
- Support other GRA activities for APAC, as required.
Key Responsibilities
- Support the MAT strategy for GRA in APAC, including supporting the distributors and regulatory consultants with the assigned activities, for GRA in APAC.
- Support the assigned MAT submissions, as agreed. Any risks, issues or potential/actual delays are communicated.
- Support and oversee the distributors and consultants as needed, with regular check in meetings as agreed.
- As an expert in the APAC region for GRA, advise and support the overall regulatory strategy and activities for products in APAC:
- Support the regulatory CMC (and strategy as needed) activities for assigned product(s) and CMC development project(s) in APAC.
- Act as CMC expert for APAC region in GRA.
- Ensure compliance with relevant regulatory legislation, guidelines and internal procedures and recorded as required.
- Keep abreast of competitive intelligence and changes in regulatory requirements and environment and assess impact, when required to support internal processes.
- Ensures performance according to internal procedures as appropriate.
- Support update/transfer of governance & procedures for GRA in APAC.
- Support with APAC related GxP audits/inspections, as required.
- Conduct APAC knowledge and activity transfer to others assigned in GRA.
- Collaborate with GRA members to enhance GRA function.
- Support other GRA activities for APAC, as required.
Position Requirements
- Life science qualification with experience in pharmaceutical regulatory affairs.
- At least 7 years+ CMC experience in regulatory affairs for APAC which includes biologicals.
- Experience in working with Japanese companies as you are required to work with Japanese companies.
- Comprehensive knowledge of regulatory processes and requirements for new submissions, MA maintenance and variation submissions in APAC.
- Knowledge and hands-on regulatory experience. Proficient in CMC data and requirements. Experience or knowledge related to submissions related to CMC for biologic product is preferable.
- Up-to-date knowledge of both existing and emerging regulatory guidance and sciences. Knowledge of ICH-GCP guidelines and international regulatory requirements such as PIC/S.
- Ability to conduct critical evaluations of analytical data.
Physical Requirements
- Travel (minimal).
- Majority of time working from home, sitting at workstation.
- Flexibility in working hours to accommodate travel and meetings.
Key Competencies specific to the role
- Excellent written and verbal communication skills, project prioritization and management skills.
- Cultural sensitivity is essential and the ability to develop consensus within a multinational organization.
- 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.
- Ability to work at a fast pace in teams in a multidisciplinary matrix organisation.
- Pro-active and problem-solving attitude.
