Associate Director, Oncology GRA

GSK • Waltham, PA

3d

About The Position

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 revolutionising 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.

Requirements

• Bachelor’s degree in biological or healthcare science.
• Minimum 2 years of Regulatory Affairs experience including interaction with Regulatory bodies
• Experience managing development, submission, and approval activities in different regions globally.
• Experience in Oncology disease area

Nice To Haves

• Advanced Scientific Degree (PhD, MD, PharmD).
• Knowledge of all phases of the drug development process in regulatory affairs.
• Capability to lead regional development, submission, and approval activities in local region(s).
• Knowledge of clinical trial and licensing requirements in all major countries in the region and, ideally, knowledge of other key Agency processes globally.
• Knowledge of relevant therapy area and the ability to further develop necessary specialist knowledge for the product or area of medicine.
• Creative regulatory problem-solving capabilities, balancing agency expectations and compliance

Responsibilities

• 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.

Benefits

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• paid caregiver/parental and medical leave
• annual bonus
• eligibility to participate in our share based long term incentive program which is dependent on the level of the role

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees