Associate Director, Oncology GRA

Associate Director Of Global Regulatory Affairs

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. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.

Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionizing the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

As an Associate Director of Global Regulatory Affairs, you will ensure the development and execution of global and / or regional regulatory strategies for assigned assets. These strategies will be in alignment with the Medicines Development Strategy / Integrated Asset Plan, ensuring compliance with internal GSK processes and policy as well as appropriate regulatory requirements. The ultimate goal is to deliver the best possible labelling that meets the Medicine Profile, commensurate with the available data.

You will engage in extensive matrix working within GSK up to the VP level and represent GSK with local regulatory agencies.

In this role you will :

• Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to plans.
• Collaborate with the Early / Medicine Development Team (EDT / MDT) or GRL to ensure a robust regulatory strategy is in place to support the development program and meet the needs of key markets.
• Work closely with local / regional commercial teams to secure the best possible labelling commensurate with the available data.
• Lead interactions with local / regional regulatory authorities.
• Proactively develop regulatory strategies that meet the needs of the local region(s), while considering the needs of other regions globally. Implement regional strategies in support of global projects.
• Ensure compliance with global / regional requirements at all stages of the product life cycle.

Why you?

Basic Qualifications & Skills :

Preferred Qualifications & Skills :

The US annual base salary for new hires in this position ranges from $134,250 to $223,750. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver / parental and medical leave.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas : respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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.