GSK

Regulatory Affairs Director / Head (BB-DAB19)

Found in: Neuvoo HK

Description:

We have long been providing differentiated, high-quality, and needed healthcare products to patients and consumers in Hong Kong and Macau. With our professional expertise and scientific know-how in innovative and established medicines, vaccines, and consumer healthcare portfolios, we are committed to helping people do more, feel better, and live longer.

Today, we employ around 250 people in Hong Kong and Macau, and we strive to support the needs of patients and consumers, ensuring access to our pharmaceuticals, vaccines and consumer healthcare products. Through collaboration with our partners, we have been supporting disease education programmes to improve health awareness and knowledge in Hong Kong and Macau.

Building trust with patients, consumers and our people locally is essential to delivering on our purpose in Hong Kong and Macau. For instance, we are recognised by the Hong Kong Council of Social Services as a "Caring Company" and in HR Asia’s 2020 list of "Best Companies to Work for in Asia" (Hong Kong edition).

Key Responsibilities

This Regulatory Affairs Director will lead Hong Kong & Macau Regulatory Affairs organisation to contribute to growth and profitability of GSK business, to protect reputation and ensure regulatory compliance in HK & Macau in alignment with GSK Regulatory Affairs objectives, policies and standards as well as with the commercial objectives for HK & Macau.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: -

  • Establish strategic direction in Pharma and Vaccines for all regulatory processes in HK & Macau in alignment with the Regulatory Affairs objectives and the other functions (e.g. Commercial, Medical);
  • Lead and manage the team in developing regulatory strategies for registering new products and line extensions and their life cycle maintenance;
  • Lead regulatory governance in HK & Macau, ensuring oversight and implementation of the processes and tracking of relevant metrics as defined by the LOC Regulatory Affairs KPIs;
  • Ensure licences are maintained in accordance with local regulations and following corporate policies, regulatory processes, standard procedures and keeping systems up to date;
  • Facilitate the strategic development and deployment of regulatory projects through prioritisation, allocation of resources and enabling communication across functions within LOCs, at the regional and global levels;
  • Ensure personal and professional development of staff through a coordinated, well managed, strategically aligned program with development objective setting and talent review processes applying the Regional Regulatory Capability Model thereby ensuring that the best people with the right skills are in place to support regulatory activities in the short term and a succession plan is developed for the longer term;
  • Develop and maintain excellent relationships with senior business partners in LOCs and functions abroad including Commercial, Medical, Pharma Supply Chain and Quality, to drive performance and maintain trust;
  • Contribute to Regional Regulatory LT and HK & Macau LT to ensure alignment between LOC and GRA;
  • Plan and control LOC regulatory budget;
  • Ensure appropriate advocacy strategies are in place to shape evolving legislation / regulatory requirements in partnership with relevant experts. Advances GSK advocacy initiatives through external networks e.g. trade associations.
  • Why You?

    Basic Qualifications

    We are looking for professionals with these required skills to achieve our goals:

  • Bachelor’s degree in life sciences / pharmacy / medicine or related discipline
  • Relevant industry experience in Regulatory Affairs of which a considerable part has been in a senior role in multinational companies including experience of leading LOC Regulatory function
  • Strong leadership, interpersonal skills and high learning agility
  • Proven track record understanding the local market’s regulatory requirements
  • Good command in both spoken and written English and Chinese
  • calendar_today6 days ago

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    location_on Kowloon, Hong Kong

    work GSK

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