Manager, Global Regulatory Affairs, Oncology
GSK
13 hours ago
Remote friendly (Collegeville, PA)
United States
Corporate Functions
As a Global Regulatory Affairs Manager, 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.
Key Responsibilities:
- Work with GRL, global/regional counterparts and local operating companies to develop and deliver regulatory strategies that meet key market requirements.
- Collaborate with cross-functional teams to align regulatory plans with Medicines 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 strategic changes.
Basic Qualifications & Skills:
- Bachelor’s degree in biological or healthcare science.
- 1+ years experience in the drug development process within regulatory affairs (preferably oncology).
- 1+ years experience in clinical trial requirements in at least one major regional/global market.
Preferred Qualifications & Skills:
- Advanced Scientific Degree (PhD, MD, PharmD).
- Ability to manage global/regional development, submission, and approval activities.
- Collaborative problem-solving and innovation within regulatory constraints.
- Digital fluency tools proficiency.
- Strong written and verbal communication skills.
- Experience working effectively in matrix teams.
- If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: annual base salary ranges $138,750–$231,250.
- Annual bonus and eligibility for share-based long-term incentive; benefits include health insurance, retirement, paid holidays, vacation, and paid caregiver/parental and medical leave.
Key Responsibilities:
- Work with GRL, global/regional counterparts and local operating companies to develop and deliver regulatory strategies that meet key market requirements.
- Collaborate with cross-functional teams to align regulatory plans with Medicines 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 strategic changes.
Basic Qualifications & Skills:
- Bachelor’s degree in biological or healthcare science.
- 1+ years experience in the drug development process within regulatory affairs (preferably oncology).
- 1+ years experience in clinical trial requirements in at least one major regional/global market.
Preferred Qualifications & Skills:
- Advanced Scientific Degree (PhD, MD, PharmD).
- Ability to manage global/regional development, submission, and approval activities.
- Collaborative problem-solving and innovation within regulatory constraints.
- Digital fluency tools proficiency.
- Strong written and verbal communication skills.
- Experience working effectively in matrix teams.
- If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: annual base salary ranges $138,750–$231,250.
- Annual bonus and eligibility for share-based long-term incentive; benefits include health insurance, retirement, paid holidays, vacation, and paid caregiver/parental and medical leave.