Manager, Global Regulatory Affairs, Oncology
Job Location:
Waltham, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 peoples 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. Were uniting science technology and talent to get ahead of disease together.
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Our approach to R&D
As a Global Regulatory Affairs Manager at GSK you will develop and execute global and regional regulatory strategies for oncology assets ensuring optimal labeling and approvals while maintaining compliance with internal and external requirements. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head and collaborate with cross-functional teams to shape development plans and regulatory interactions across multiple regions. We value clear thinking collaboration practical problem solving and a patient-first mindset.
Key Responsibilities:
Work closely with GRL global/regional counterparts and local operating companies to develop and deliver robust regulatory strategies that meet key market requirements.
Collaborate with cross-functional teams to align regulatory plans withMedicines Development Strategy and Integrated Asset Plan.
Support interactions reviews and submissions with regional/local regulatory authorities for product development and approval.
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.
Drive process improvement innovation and performance excellence through the development and implementation of strategic changes.
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
Bachelors degree in biological or healthcare science.
1 years experience in the drug development process within regulatory affairs preferably oncology.
1 years of experience in clinical trial requirements in at least one major regional/global market.
Preferred Qualifications & Skills:
Please note the following skills are not necessary just preferred if you do not have them please still apply:
Advanced Scientific Degree (PhD MD PharmD).
Proven ability in managing global andregional development submission and approval activities.
Demonstrated ability to foster collaborative environments proactively resolve challenges and develop innovative solutions within regulatory constraints.
Proficiency in digital fluency tools to enhance project delivery efficiency and innovation.
Strong written and verbal communication skills for clarity and impact.
Experience working effectively in matrix teams.
#LI-GSK
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 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 were 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.
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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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Manager
About Company
About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
