Global Regulatory Affairs Director

Vor 5 Tagen

Baar, Schweiz GSK Vollzeit
Site Name: GSK HQ, Baar Onyx, UK - Hertfordshire - Stevenage
Posted Date: Nov 15 2024

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.

Are you passionate about regulatory strategy and oncology? We are looking for a driven and motivated Global Regulatory Affairs Director who will be instrumental in developing and executing global and regional regulatory strategies for assigned assets in our growing oncology portfolio. Your efforts will ensure compliance with regulatory requirements while optimising the development programme to meet the needs of patients in global markets.

In this role you will:

  • Strategic Development: Act as the Global Regulatory Lead (GRL), or collaborate as a regional lead with the GRL, and Global Regulatory Therapeutic Area (TA) Head to develop and implement robust regional regulatory strategies.
  • Matrix Leadership: Engage in extensive matrix working within GSK, including with senior management, and represent GSK with local regulatory agencies.
  • Global Collaboration: Work closely with global and regional counterparts, as well as local commercial teams, to ensure a harmonized approach to regulatory submissions and approvals.
  • Compliance: Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
  • Regulatory Intelligence: Conduct regulatory intelligence activities to assess the competitive landscape and its impact on regulatory strategies.

Basic Qualifications & Skills:

  • Bachelor’s degree in biological or healthcare science.
  • Extensive experience in pharmaceutical industry Regulatory Affairs.
  • Proven track record of interactions with Health Authorities.
  • Capable of leading development, submission and approval activities in different region(s) globally.
  • Ability to develop necessary specialist knowledge for the product in a specific oncology disease area.

Preferred Qualifications & Skills:

  • Advanced Scientific Degree (PhD, MD, PharmD).
  • Knowledge of the drug development process in regulatory affairs.
  • Awareness of global regulatory processes, including submission and approval activities.
  • Understanding of clinical trial and licensing requirements.
  • Strong matrix working skills with the ability to facilitate dialogue and contribute to strategic changes.
  • Creative problem-solving abilities with a balanced approach to regulatory expectations and compliance.
  • Ability to coach and mentor others.

Closing Date for Applications – 31 Jan 2025 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles.

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