Regional/Local Senior Regulatory Specialist

Regional/Local Senior Regulatory Specialist

Our client is one of the most diverse Pharmaceutical MNC's in the world. Rapidly expanding its operations in Asia Pacific Region.

Key Responsibilities

Regulatory Affairs

• To assist Head of Regulatory Affairs Head (HRA) to provide leadership and strategic direction of regulatory activities for assigned portfolio in the assigned markets
• To interface with other function lines to ensure collaborative connectivity with these key stakeholders, and a more focused Regional Regulatory Affairs (RA) approach to supporting country and regional business objectives and ensure product access.
• Delivery of innovative pharmaceutical products with competitive labelling to the region in timely manner.
• Be a recognized partner for internal in-country stakeholders and above-country.
• Establish, and maintain, strong relationship with local MAH (distributors) and regulatory authorities in in the assigned markets
• Environment shaping and advocacy activities within country / region.
• Develop strong partnerships with in-country (e.g. Commercial Lead, Medical, Marketing, Supply Chain) & above country to facilitate the development & implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
• Provide strategic contribution to the Global RA leadership.
• Responsible for developing and supporting relationships with key external agencies. Support the Health Authority interface throughout the development and lifecycle of a product. Facilitate meetings and participate in negotiations with regulatory authority as necessary.
• 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.

Required Education, Experience, Skills

• Degree from recognized university.
• Minimum 3-5 years of experience in regionally/locally.
• Pharmaceuticals & BioPharma experience

Location : Central, Singapore

Kindly indicate your current/last salary details and your notice period

If the above speaks to you, we'd love to hear from you. Please send in your updated CV to [Confidential Information] (Gerard James Rozario, Reg No: R21101884) if you feel there is a fit with your experience and interest. You may forward this great opportunity to someone who would be a great fit for this role.

All information will be kept strictly confidential. We regret to inform that only successful applicants will be contacted.

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