Manager, Global Regulatory Affairs (Oncology)

GSK • Rockville, MD

1d

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 revolutionizing the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. Are you a driven and motivated regulatory affairs professional? As a Global Regulatory Affairs Manager at GSK, you will play a pivotal role in developing and executing global and regional regulatory strategies for our assets. Your efforts will ensure that our development programs meet the needs of key markets and align with the Medicines Profile. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head, ensuring timely submission and approval of clinical trial applications.

Requirements

• Minimum of a Bachelor’s degree in biological or healthcare science.
• Minimum of 1 year experience in the drug development process within regulatory affairs.
• Proven ability to manage development, submission, and approval activities in different regions globally.
• Minimum of one year of experience in clinical trial requirements in at least one region (EU or US) and ideally familiarity with other key agency processes globally.

Nice To Haves

• Advanced Scientific Degree (PhD, MD, PharmD).
• Minimum of two years of experience in Oncology (Hematology or Solid Tumor) regulatory affairs.
• Strong matrix working skills, with the ability to facilitate dialogue and idea contribution among team members.
• Proactive problem-solving skills to identify and resolve project or team issues in advance.
• Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.
• A focus on continuous improvement and excellence, with the ability to challenge current processes and recommend strategic changes.
• Ability to develop networks within GSK to secure support and achieve project outcomes.

Responsibilities

• Regulatory Strategy: Proactively develop or implement regulatory strategies to ensure the submission and approval of clinical trial applications and other deliverables within agreed timescales.
• Cross-functional Collaboration: Ensure effective interaction with cross-functional teams, global/regional counterparts, and local operating companies.
• Compliance: Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
• Regulatory Intelligence: Assess precedent, regulatory intelligence, and the competitive environment to inform and refine regulatory strategies.

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager