Director, EU Regulatory Strategy
Moderna Therapeutics is seeking a Director of EU Regulatory Strategy to support clinical development programs across therapeutic areas. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as unprecedented new drug modality. The Sr. Director/Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans for assigned programs, and as an expert within Regulatory, will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate.
Here's What You'll Do:
- Develops content, format and accountability for EU regulatory submissions and related amendments.
- Advises project teams regarding the development and implementation of EU regulatory strategy through the clinical development processes. Identifies potential areas of regulatory concern and responds to new government/regulatory developments.
- Establishes and maintains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's applications.
- Reviews and approves technical data and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.
- Develops, implements, and reviews current policies and practices in compliance with EU regulatory agencies.
- Serves as EU regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
- Monitors regulatory publications to keep apprised of new or changing EU regulatory developments and potential strategic impact.
- Reviews all external materials for regulatory compliance.
- Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory bodies.
- Represent Regulatory Affairs on cross-functional project teams
- Ensure alignment of regulatory strategy and plan on a continuous basis within the Moderna ecosystem
- May be responsible for line management and development of direct reports
Here's What You'll Bring to the Table:
- BA/BS degree in a scientific/engineering discipline
- 15+ years of experience in the Pharmaceutical industry
- 8+ years of experience in Regulatory strategy, including specifically : rare diseases
- Strong knowledge of current EU regulations, including specifically: e.g. novel regulatory pathways.
- Exceptional written and oral communication
- Experience with developing and implementing competitive regulatory strategies
- Demonstrated track record in securing product approvals and maintaining a complex portfolio
- Experience dealing with broad range of stakeholders at all levels internal and external to the company
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance - preferably from at least both US and EU
- Direct experience of leading regulatory authority meetings in different phases of drug development
- Preferred: Graduate degree in a scientific discipline or other relevant graduate discipline or professional certification
Why Join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale, and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.