Manager, Global Regulatory Strategy - Oncology
About The Position
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: 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.
Requirements
- Bachelor’s degree in life sciences, pharmacy, medicine or a related field.
- 1+ years of experience in the drug development process within regulatory affairs.
- Experience with oncology drug development, including clinical trial applications and regulatory submissions.
- Experience working in matrix teams across functions and regions.
Nice To Haves
- Advanced Scientific Degree (PhD, MD, PharmD).
- 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
- Proactively develop or implement regulatory strategies to ensure the submission and approval of clinical trial applications and other deliverables within agreed timescales.
- Ensure effective interaction with cross-functional teams, global/regional counterparts, and local operating companies.
- Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
- Assess precedent, regulatory intelligence, and the competitive environment to inform and refine regulatory strategies.
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
