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

GSK • Rockville, MD

22h • $138,600 - $231,000 • Hybrid

About The Position

GSK is seeking a Regulatory Affairs professional to join its Respiratory, Immunology & Inflammation (RII) Global Regulatory Strategy team. The Manager / Associate Director develops and executes appropriate global and regional regulatory strategies for assigned assets, ensuring development programs address the needs of identified key markets and the Medicines Profile and align with the Medicines Development Strategy / Integrated Asset Plan. The role ensures adherence to GSK processes and policies and applicable regulatory requirements, supporting the best possible labelling consistent with available data.

The position reports directly to a Director (Team Lead) for Therapeutic Groups (RII). It may be based at GSK HQ in London, Wavre, Belgium, or Upper Providence, Durham, or Rockville in the United States. The role is hybrid, with regular on-site collaboration required and a typical schedule of two to three days on-site per week.

The successful candidate will develop subject matter expertise and work with a wide range of stakeholders. The role calls for experience handling complex technical situations, a clear problem-solving approach, strong people skills, and the ability to influence others and drive performance.

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 and knowledge of all phases of the drug development process.
• Ability to develop the specialist knowledge required for the product or medicine area.
• Proficiency with digital tools and AI to enhance project delivery, efficiency, and innovation.
• Experience working in complex technical situations and a demonstrable problem-solving approach.
• Strong people skills and a proven ability to influence others and drive performance.

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 therapeutic area, especially Immunology & Inflammation.

Responsibilities

• Proactively develop regulatory strategies that deliver the needs of local regions while taking into account the needs of other regions globally.
• 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 precedents, intelligence, and the competitive environment for the region, and determine their impact on an asset's regulatory strategy.

Benefits

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

What This Job Offers

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