Job Overview
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Associate Director Global Regulatory Strategy (GRS) (m/f/d) will lead and execute regulatory strategies for global and regional assets, ensuring optimal labeling and approvals while maintaining compliance with internal and external requirements. Work in cross‑functional and matrix environments to deliver project objectives across multiple regions.
Responsibilities
* Develop and implement global/regional regulatory strategy for assigned assets in alignment with Medicines Development Strategy and Integrated Asset Plan.
* Work closely with Early/Medicine Development Teams (EDT/MDT) or Global Regulatory Lead (GRL) to ensure robust regulatory strategies that meet key market requirements.
* Manage interactions, reviews, and submissions with regional/local regulatory authorities for product development and approval.
* Collaborate with commercial teams in the local region to secure the best possible labeling based on available data.
* Assess regulatory intelligence, precedents, and competitive landscape to inform strategy development and improve decision‑making.
* Ensure compliance with global, regional, and local regulatory requirements throughout the product lifecycle.
* Foster strong matrix working relationships within GSK (to VP level) and facilitate dialogue across teams to optimize outcomes.
* Drive process improvement, innovation, and performance excellence through the development and implementation of strategic changes.
Qualifications & Skills
* Minimum: Bachelor's degree in Biological or Healthcare Science.
* Experience in all phases of drug development process, preferably in regulatory affairs.
* Experience in Oncology Global Regulatory Affairs.
* Proven expertise in leading global and regional development, submission, and approval activities.
* Comprehensive knowledge of clinical trial and licensing requirements across major regional/global markets.
* Ability to derive creative and compliant solutions to regulatory challenges while balancing agency expectations.
* Strong communication skills, particularly in writing, with clarity and impact.
Preferred Qualifications & Skills
* PhD in Biological or Healthcare Science.
* Demonstrated knowledge of oncology therapy areas and ability to develop specialist knowledge of assigned assets.
* Proficiency in digital fluency tools to enhance project delivery, efficiency, and innovation.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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