Director of Regulatory Strategy
5 days ago
The Role:
Moderna is seeking a seasoned professional to lead the development and implementation of global regulatory strategy for its Latent Viruses mRNA vaccines. The ideal candidate will have a strong background in regulatory affairs, with a focus on vaccine development and a proven track record of success in navigating complex regulatory environments.
This is a critical role that requires a strategic thinker with excellent communication and leadership skills. The Director of Regulatory Strategy will be responsible for developing and implementing a comprehensive regulatory strategy that aligns with the company's business objectives and ensures compliance with relevant regulations and guidelines.
The successful candidate will have a deep understanding of the regulatory landscape and be able to anticipate and address potential challenges. They will also be able to articulate a clear and compelling regulatory strategy that highlights risks and opportunities, and leverage the mRNA platform technology to drive business success.
Key Responsibilities:
- Develop and implement a global regulatory strategy that aligns with the company's business objectives
- Lead the development and submission of regulatory documents to health authorities
- Ensure compliance with relevant regulations and guidelines
- Collaborate with cross-functional teams to ensure regulatory risk assessment and mitigation plans are developed and aligned
- Provide strategic direction and oversight for the preparation, submission, and follow-up of regulatory documents
- Liaise with health authorities, internal stakeholders, and external partners to ensure business objectives are achieved
Requirements:
- BA/BS degree in a scientific/engineering discipline, advanced degree preferred
- 10+ years of experience in the pharmaceutical industry, with a focus on regulatory affairs
- 6+ years of experience in regulatory strategy, including vaccine development
- Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to infectious disease vaccine programs
- Strong experience with CTD format and content of regulatory filings
- Experience with developing and implementing competitive regulatory strategies
- Demonstrated track record in maintaining a complex portfolio
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, preferably from at least both US and EU
- Direct experience of leading regulatory authority meetings in different phases of drug development
About Moderna:
Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop innovative medicines. We are committed to making a meaningful impact on the lives of patients and are seeking talented individuals to join our team. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
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