Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation)

GSK • Rockville, MD

2d • $138,600 - $231,000 • Hybrid

About The Position

The Manager / Associate Director joins the Respiratory, Immunology & Inflammation (RII) Global Regulatory Strategy team and reports directly to a Director (Team Lead) for Therapeutic Groups (RII). The role develops and executes appropriate global and regional regulatory strategies for assigned assets, ensuring development programs address key-market needs and the Medicines Profile while remaining consistent with the Medicines Development Strategy / Integrated Asset plan.

The role ensures compliance with GSK processes and policies and applicable regulatory requirements, and supports the development of the best possible labelling based on available data. It involves working with global and regional counterparts and commercial teams, managing regulatory interactions and review processes, and assessing regulatory precedents, intelligence, and the competitive environment.

The position is hybrid, with regular on-site collaboration required and a typical schedule of two to three days on-site per week. Applicants may be based at GSK HQ in London, Wavre, Belgium, or Upper Providence, Durham, or Rockville in the USA. The posting also lists salary ranges for the United States and Belgium. US new-hire base salary is $138,600–$231,000 for specified locations; Belgium's range is EUR 89,250–148,750. The position may include an annual bonus and eligibility for a share-based long-term incentive program, depending on role level. Listed US benefits include health care and other insurance, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Requirements

• Degree in a relevant scientific or technical discipline, or very strong relevant experience.
• Relevant regulatory affairs experience in the EU and/or US and other major markets, including developing and implementing regional strategies and managing regulatory interactions, submissions, and review processes.
• Clinical regulatory experience, with knowledge of all phases of the drug development process.
• Ability to develop the necessary specialist knowledge for the product or area of medicine.
• Proficiency in digital tools and AI to enhance project delivery and drive efficiency and innovation.
• Strong experience working in complex technical situations and a demonstrable problem-solving approach.
• Strong people skills and a proven ability to influence people to achieve and drive performance.
• Strong stakeholder liaison capabilities.

Nice To Haves

• Experience in regulatory affairs across all phases of the drug development process.
• Knowledge of clinical trial and licensing requirements in all major countries in the region, and ideally knowledge of other key agency processes globally.
• Experience in a relevant therapy area, especially Immunology & Inflammation.

Responsibilities

• Develop regulatory strategies that meet local-region needs while taking the needs of other global regions into account.
• Implement regional strategies in support of the global project.
• Manage regulatory interactions and review processes in local regions.
• Ensure appropriate interaction with global and regional counterparts and local commercial teams.
• Ensure compliance with global and regional requirements throughout all stages of product life.
• Assess regulatory precedent, regulatory intelligence, and the competitive environment for the region, and determine their impact on an asset's regulatory strategy.
• Develop and deliver subject-matter expertise across GSK.

Benefits

• Annual bonus (may be offered; dependent on role level).
• Eligibility to participate in a share-based long-term incentive program (dependent on role level).
• Health care and other insurance benefits for employees and family.
• Retirement benefits.
• Paid holidays.
• Vacation.
• Paid caregiver, parental, and medical leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager