Job title: Regulatory Affairs Head, Hong Kong & Taiwan

About the job

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

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!