Director, Regulatory Affairs - Specialty

Gsk Plc

7+ years

Not Disclosed

Remote, USA

10 Jan. 17, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Director – GSK
Locations: UK – London (New Oxford Street), Stevenage, Wavre
Posted Date: January 9, 2025

Job Purpose:
As the Regulatory Director at GSK, you will be responsible for the development and execution of regional regulatory strategies for assigned assets, ensuring alignment with the overall Medicines Development Strategy. You will play a key role in ensuring compliance with both internal GSK policies and regional regulatory requirements, focusing on achieving the best possible product labeling based on available data.

Key Responsibilities:

Accountable to the Global Regulatory Lead (GRL) and Global Regulatory TA Head for developing and delivering appropriate regional and/or global regulatory strategies.
Lead the planning and execution of regulatory strategies with a multi-year horizon, working collaboratively across GSK to VP level.
Serve as the primary point of contact for assigned assets, managing both regional and global regulatory strategies.
Work closely with local/regional commercial teams to secure the best possible labeling based on available data.
Lead interactions with local and regional regulatory authorities and oversee the review processes in the local region.
Ensure compliance with regional regulatory requirements throughout the product lifecycle.
Advocate persuasively for regulatory approaches to senior leaders within GSK and health authorities.
Provide regulatory assessments for potential in-licensing molecules.

Why You?

Basic Qualifications:
We are looking for professionals with the following qualifications to help us achieve our goals:

Bachelor’s degree in a related field.
Experience in Regulatory Affairs within the pharmaceutical industry.
Familiarity with working with Global Health Authorities and managing submissions for pharmaceutical products.

Preferred Qualifications:
If you have the following characteristics, it would be a plus:

PhD or Master's degree in life sciences or pharmacy.
Strong technical knowledge to assess regulatory compliance of pharmaceutical products.
Experience interacting with regulatory officials and supporting advocacy initiatives.

Why GSK?
GSK is a global biopharmaceutical company with a clear purpose: to unite science, technology, and talent to get ahead of disease together. We focus on improving the health of billions of people through vaccines, specialty medicines, and general treatments across key therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.

We believe that our success depends entirely on our people. GSK is a place where you can thrive, feel valued, and be encouraged to be your best. We are committed to making GSK a welcoming, inclusive, and dynamic workplace. If you share our ambition, join us as we work to get Ahead Together.

Application Instructions:
Apply by January 23, 2025 by submitting your CV or cover letter.

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Director, Regulatory Affairs - Specialty

Job Description

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