Regulatory Affairs Head, Hong Kong & Taiwan

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Job purpose

• Increase the accessibility of our products to patients in Taiwan and Hong Kong.

• Obtain and maintain approvals of local products in compliance with authorities’ requirements and facilitate registration and approval of core products and NCE’s. 

• To be responsible for the daily management of drug regulatory operations in accord with the business strategy and plan.

Key Accountabilities

• Key interface with local authorities.

• Ensure corporate compliance with local regulations.

• Works with Marketing/Medical and cross-functional team in the development of promotional material to support the prices of the brands and value thereof.

• Develops a network of contacts within Corporate and with affiliate Sanofi companies.

• Provide guidance, evaluate and communicate relevant issues and developments within the local regulatory environment and advise senior corporate regulatory and local management with respect to their implications to the business.

• Determine and implement a strategy for local regulatory affairs to ensure effective maintenance of existing product.

• Implement the strategy for the timely approval of new products, in collaboration with corporate

• Plan, organize and optimize all activities.

• Represent and lobby regulatory interests to professional Associations.

• Manage Human and Financial Resources.

• Ensure the local regulatory safety reporting to health authorities as appropriate.

• Review and approve the promotional materials.

• Responsible for assessing the risk of own domain responsibility.

• Sanofi employee must understand of own roles and responsibilities in avoiding health risk (Health), preventing accidents (Safety) and environment protection (Environment). Involved in any such activities must comply with HSE policy.

• Perform other duties as assigned by management.

About you

Education

• Scientific background (medicine, pharmacy, regulatory) essential, business education desirable

Experience & Knowledge

• At least 10+ years experience in pharma business (Sales/Marketing/ Regulatory/Medical), with experience in dealing with Government officials and KOLs. 

• Strong cross functional communication skills

• Proven management experience and success in the Regulatory field within an international environment (knowledge or practice in drug development and regulatory affairs) and active participation in local regulatory professional organization; good working knowledge of legal, financial and people-management issues

Core Competencies/Skills

• Confident to interact at a high level in Government and Industry circles

• Ability to work with different functions within the company on matrix management projects

• Outcome and results orientated

• Demonstrates success as a regulatory professional within a multinational environment

• Demonstrates excellent knowledge and practice in the regulatory field

• Demonstrates capacity to learn and understand business, legal. Financial and human resource issues and their impact on the regulatory function

• Able to lead by example and foster professionalism in the team through continuous motivation and effective coaching

• Highly focused and drives to set for him/herself (and help others to set for themselves) ambitious objectives

• Capacity to judge the competency of the team and able to initiate change

• Ability to constantly self-challenge and challenge others in a constructive way

• Quick to analyze and take action without compromising quality; utilizes effective negotiation skills

• Shows integrity, tenacity, resilience and adaptability in complex situations and often changing environment; able to handle pressure and commit to and respect deadlines

• Utilizes excellent communication skills and demonstrates intercultural adaptability and sensitivity

• Demonstrates good English language skills