Regulatory Affairs Manager

1 day ago

Singapore EPS COMPUTER SYSTEMS PTE LTD Full time
Roles & Responsibilities

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.

Tell employers what skills you have

GxP
Management Skills
Leadership
Analytical Skills
Legislation
Regulatory Affairs
ISO
Regulatory Strategy
Strategy
Chemistry
Compliance
Medical Devices
Competitive Intelligence
Communication Skills
Team Player
Regulatory Requirements
Customer Service
Life Sciences
Manufacturing
Japanese

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