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Regulatory Portfolio Manager
2 months ago
Job Type: 8-month contract
Location: Hybrid/Remote
Hourly Rate: £60 per hour
About the Role:
The Regulatory Portfolio Manager will partner with the Global Regulatory Lead and wider Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets.
Key Responsibilities:
- Partner with the Global Regulatory Lead and wider Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets.
- Co-lead Global Regulatory Sub-Team meetings to ensure high-quality discussions and decisions.
- Develop and maintain the asset's global regulatory book of work and Global Submission Plan.
- Track key regulatory milestones and maintain global submission plans.
- Provide operational support to the Global Regulatory Lead on strategic global regulatory documents.
- Coordinate the rapid response process to ensure quality and timely responses to health authority queries globally.
- Represent the Global Regulatory Lead in team meetings as needed.
Requirements:
- Degree or equivalent in a healthcare-related field.
- Direct regulatory experience with developing knowledge of US and/or EU procedures.
- Able to lead through influence and build alignment with stakeholders to deliver projects to plan.
- 3-5 years of experience in Regulatory Affairs.
- Strong Regulatory Strategy experience.
