Head of Regulatory Affairs Thailand
1 week ago
Job Summary
Regulatory Sciences Team Lead is responsible for providing leadership and strategic direction of PBG products in country, management of Regulatory Sciences team in country, to interface with other function leads (e.g. GCMC, GLS, SOS, PGS, Commercial, Medical) to ensure collaborative connectivity with these key stakeholders, and a more focused regional RA approach to supporting country and regional business objectives and ensure product access (PNS). He/she is responsible to deliver innovative pharmaceutical products with competitive labelling to the region in timely manner; be a recognised partner for internal in-country stakeholders (GCMC, SOS, GLS, PGS, Medical, Commercial etc.); establish, and maintain, strong relationship with the regulatory authorities as well as environment shaping and advocacy activities within country/region.
Job Responsibilities
- Lead and manage the RA team in the development of regulatory strategies to support the registration of new, major variations and lifecycle management. Ensure that regional RA teams provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives.
- Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems (e.g. CMC change control, product labelling, etc.) are in place, and that the RA staff (permanent and contract) are properly trained in these systems and procedures.
- Oversee and manage the completion of NDA and Lifecycle (LC) submissions and approvals as per established GRS-I performance metrics and Alliance Partner model.
- Responsible for ensuring that all regulatory activities (new product submissions, existing licenses, etc.) are compliant with local regulations, requirements and practices.
- Provide input to the relevant stakeholders for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business/commercial plans.
- Provide consultative and intelligence support to internal stakeholders. Advise where necessary, on the development of responses to regulatory queries, including coordination on the receipt, distribution and response to regulatory queries on assigned projects, consistent with departmental procedures.
- Responsible for the development, leadership and performance management of the direct reports team to achieve company objectives. Develop and enhance the capabilities and capacities of the RA teams through the identification and implementation of training and development needs.
- Develop strong partnerships with in-country and regional teams (e.g. Country Managers, Medical, Marketing, Supply Chain) and above country Therapeutic Area and Regional Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
- Provide strategic contribution to the GRA-I leadership.
- Contribute to change management and continuous improvement projects (Regulatory Operational Excellence).
- Responsible for developing and supporting relationships with key external agencies. Support the Health Authority interface throughout the lifecycle of a product. Support long-term and positive relationship characterized by integrity, quality, compliance and leadership. Facilitate meetings and participate in negotiations with regulatory authority as necessary.
- Active participation in regional trade organization and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand regional regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business.
People Management:
- Foster continual learning to promote regulatory excellence.
- Manage the performance of direct reports to achieve agreed objectives.
- Identify and address training and developments needs to encourage and talent development and succession planning.
- Keep team continuously engaged to retain/attract talent.
Project Management:
- Oversee and/or facilitate strategic process improvements initiatives.
- Ensure product strategies, submission and approval time lines.
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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