Director, Regulatory Affairs, Specialty

GSK; Cambridge (MA); On-site; USD 166,000 - 278,000; Full time

Job summary

An established industry player is seeking a Director of Regulatory Affairs to shape and execute regional regulatory strategies for innovative pharmaceutical products. This pivotal role involves collaboration with global teams and local regulatory agencies, ensuring compliance with all regulations while advocating for product approval. The ideal candidate will possess a strong background in regulatory affairs, with a focus on strategic planning and effective communication. Join a dynamic team committed to improving health worldwide and fostering an inclusive environment where your expertise can thrive.

Benefits

Health Care

Retirement Plans

Paid Holidays

Parental Leave

Qualifications

• Experience in Regulatory Affairs within a pharmaceutical organization.
• Strong technical knowledge for regulatory compliance assessment.

Responsibilities

• Develop and deliver regional and global regulatory strategies.
• Lead interactions with local/regional regulatory authorities.

Skills

Regulatory Affairs

Pharmaceutical Submissions

Collaboration with Regulatory Authorities

Strategic Planning

Education

Bachelor's Degree

PhD or Master's Degree in Life Sciences or Pharmacy

Job description

Join to apply for the Director, Regulatory Affairs, Specialty role at GSK

Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville

Posted Date: Apr 29, 2025

Job Purpose

Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s), consistent with Medicines Development Strategy. This involves aligning with global regulatory approaches and ensuring compliance with internal GSK policies and regional requirements to deliver optimal labeling based on available data.

Key Responsibilities

• Develop and deliver regional and/or global regulatory strategies in collaboration with GRL and Global Regulatory TA Head.
• Serve as the single point of contact for assigned assets, managing regional and global strategies.
• Plan on a multi-year horizon, working extensively within GSK and representing the company with local regulatory agencies.
• Collaborate with local/regional commercial teams to secure appropriate labeling.
• Lead interactions with local/regional regulatory authorities.
• Ensure strategies meet regional needs while supporting global project goals.
• Lead regulatory review processes and interactions in local regions.
• Maintain compliance throughout the product lifecycle.
• Advocate persuasively to senior leaders and health authorities.
• Assess potential of license molecules.

Why you?

Basic Qualifications:

• Bachelor’s degree
• Experience in Regulatory Affairs within a pharmaceutical organization
• Experience working with global health authorities and submissions for pharmaceutical products

Preferred Qualifications:

• PhD or Master’s degree in life sciences or pharmacy
• Strong technical knowledge for regulatory compliance assessment
• Ability to interact with regulatory officials and support advocacy initiatives

Salary ranges from $166,650 to $277,750, plus annual bonus and long-term incentives. Benefits include health care, retirement, paid holidays, and parental leave. Visit GSK US Benefits Summary for details.

Why GSK?

GSK is a global biopharma committed to uniting science, technology, and talent to combat disease and improve health worldwide. We foster an inclusive environment where employees can thrive and grow. Join us to be part of our journey to get Ahead Together.

If you need accommodations to apply, contact the GSK Service Centre.

GSK is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, gender identity, sexual orientation, parental status, nationality, age, disability, genetic information, military service, or other protected categories.