Director, Healthcare Management, Healthcare

Director, Global Regulatory Affairs

UK – London, New Oxford Street, Durham Blackwell Street, Italy – Siena, Stevenage, Switzerland – Zug, Upper Providence, USA – Massachusetts – Waltham

Are you passionate about making a difference in global healthcare? At GSK, we are dedicated to improving lives by delivering innovative medicines and vaccines. As a Director of Regulatory Affairs, you will play a pivotal role in shaping regulatory strategies that ensure the availability of safe and effective treatments worldwide.

Accountable to GRL and Global Regulatory TA Head, the Director of Regulatory Affairs will lead the development of regional/global regulatory strategies and their execution for assigned asset(s) aligned with the overall Medicines Development Strategy.

• Ensure the regulatory strategy will deliver the needs of the local region(s), considering the needs of other regions globally.
• Implement the regional strategy(s) in support of the project globally.
• Lead regulatory interactions and the review processes in local region.
• Ensure appropriate interaction with regional commercial teams in local region.
• Ensure compliance with regional requirements at all stages of product life.
• Advocate persuasive approaches to senior leaders in GSK and in health authorities.
• Capable of providing assessment of potential in license molecules.

• Bachelor's degree in Biological or Healthcare Science, with previous experience in similar strategic international regulatory affairs positions.
• Extensive experience in regulatory affairs across all phases of drug development.
• Proven track record in leading regional development, submission, and approval activities.
• Experience working on clinical trial and licensing requirements in major countries.

• PhD in Biological or Healthcare Science.
• Experience with projects involving little or no precedence in regulatory affairs.
• Expertise in developing product or therapeutic knowledge in new areas.
• Familiarity with digitalization in regulatory strategy to enhance decision-making and innovation.
• Proven ability to deliver creative solutions to regulatory challenges while ensuring compliance.
• Exceptional communication and leadership skills, with the ability to build strong networks and influence stakeholders.

• If you are based in Cambridge, MA;
  Waltham, MA;
  Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $166,650 to $277,750.
• The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role.
• In addition, this position offers an annual bonus and eligibility to participate in our share‑based long‑term incentive program, which is dependent on the level of the role.
• Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
• If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, focusing on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Please contact us at UKRe for adjustments or any other questions.