Director, Global Regulatory Affairs

Director, Global Regulatory Affairs

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. Join us and be part of a team committed to creating healthier communities.

Job Purpose

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.

Planning will be on a multiple year horizon, with delivery requiring extensive matrix leadership within GSK to VP level and representing GSK with local regulatory agency.

This role works closely with local / regional commercial teams to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.

Key Responsibilities

• 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.

Why You?

Basic Qualifications

• Bachelor’s degree in Biological or Healthcare Science, with previous experience in similar strategic international regulatory affairs positions.
• 10+ years of 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.

Preferred Qualifications

• 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.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

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, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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