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About the role
Key responsibilities & impact- Represents the regulatory project and submission management (RPSM) group in cross-functional planning to develop global regulatory submission and execution plans in line with the client’s needs and regulatory team goals.
- Partners with document providers to project manage the timely receipt of submission ready documents for inclusion in global dossiers.
- Communicates external agency submission standards and internal business submission processes to ensure compliance and efficiency in the delivery of submission.
- Ensures that company is aware and responsive to external guidelines, regulations, changes in the marketplace and other information relating to global regulatory project and submission management.
Requirements
What you’ll need- A relevant educational background in a life-sciences discipline
- Some previous experience in submissions, regulatory operations or publishing.
- Strong project management skills
- Fluency in English
- Need experience in: Microsoft Project (needed)
- Experience supporting BLA’s/ IND’s
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submission managementproject managementsubmissionsregulatory operationspublishingBLAIND
Soft Skills
communicationcomplianceefficiency