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Regulatory Affairs Strategy Leader
2 months ago
Senior Director or Director of Regulatory Affairs Strategy
About the Role
We are seeking a highly skilled Regulatory Affairs Strategy Leader to join our team at Barinthus Biotherapeutics. As a key member of our organization, you will be responsible for leading the global regulatory strategy for our cutting-edge immunotherapeutic products.
Key Responsibilities
- Develop and Implement Regulatory Strategies: Collaborate with cross-functional teams to develop and implement regulatory strategies that align with our product development plans.
- Manage Regulatory Documents and Interactions: Oversee the preparation and submission of regulatory documents, including strategic regulatory documents and interactions with global agencies.
- Drive Regulatory Excellence: Ensure compliance with regulatory requirements and industry standards, and identify opportunities for process improvements.
- Collaborate with Stakeholders: Work closely with internal stakeholders, including product development teams, to ensure regulatory strategies are aligned with product development plans.
Requirements
- Biologics Regulation Expertise: Experience in the regulation of biologics, including immunomodulating therapies and vaccines, is highly valued.
- Product Development Insight: In-depth experience with clinical and non-clinical regulatory aspects of products in development.
- Global Regulatory Knowledge: Strong experience with biologics registration requirements in Europe and familiarity with international regulations (UK MHRA essential, US FDA preferred).
- Regulatory Lifecycle Proficiency: Solid understanding of Regulatory Life Cycle Management and eCTD format for regulatory filings.
- Submission Mastery: Demonstrated ability in drafting and organizing regulatory submissions, amendments, and supplements.
What We Offer
- Opportunity to Make a Difference: Join a team that's shaping the future of healthcare and making a real difference in people's lives.
- Collaborative Environment: Work in a dynamic and collaborative environment with a team of experts who share your passion for regulatory affairs.
- Professional Growth: Develop your skills and expertise in a rapidly evolving industry, with opportunities for career advancement.
- Competitive Compensation and Benefits: Enjoy a competitive salary and benefits package, including pension plans, healthcare, and share options.
About Barinthus Biotherapeutics
We are a rapidly growing biotechnology company dedicated to developing innovative immunotherapeutic products that improve human health. Our team is passionate about making a difference in people's lives, and we're looking for talented individuals who share our vision.
