Director, Regulatory Affairs - Specialty Medicine

Director, Regulatory Affairs - Specialty Medicine

Join GSK as a Regulatory Director - Drive Innovation in Specialty Medicines

Are you ready to make a meaningful impact in the world of specialty pharmaceuticals? At GSK, we're uniting science, technology, and talent to get ahead of disease together. We're looking for a Director, Regulatory Affairs to lead the development and execution of regulatory strategies for our cutting-edge Specialty pipeline.

Your Purpose

As a Director of Regulatory Affairs in our Global Regulatory Affairs team, you'll play a pivotal role in shaping and delivering regulatory strategies that support the development and approval of innovative specialty medicines. You'll ensure our products meet regional regulatory requirements while achieving the best possible labelling outcomes-ultimately helping patients access transformative treatments faster.

What You'll Do

• Lead Strategy Development: Design and implement robust regional and global regulatory strategies for assigned assets, aligned with the overall Medicines Development Strategy.
• Be the Key Contact: Act as the primary regulatory point of contact for your asset(s), working across global teams and engaging with local regulatory authorities.
• Drive Regulatory Success: Collaborate with commercial teams to secure optimal labeling and lead regulatory interactions and submissions in your region.
• Ensure Compliance: Maintain full compliance with internal policies and regional regulatory requirements throughout the product lifecycle.
• Influence and Advocate: Confidently represent GSK to regulatory agencies and senior internal stakeholders, advocating for innovative approaches and regulatory solutions.
• Evaluate Opportunities: Provide expert assessments of potential in-licensing opportunities.

Why You?

Basic Qualifications

We're looking for professionals with:

• A Bachelor's degree
• Proven experience in Regulatory Affairs within the pharmaceutical industry
• Hands-on experience with regulatory submissions and interactions with health authorities

Preferred Qualifications

You'll stand out if you also bring:

• A Master's or PhD in life sciences or pharmacy
• Strong technical knowledge of regulatory compliance
• Excellent communication skills and the ability to influence regulatory officials and internal leaders

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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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