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Senior Regulatory Strategy Manager

2 months ago

Trenton, New Jersey, United States Moderna Full time

Position Overview:

Moderna Therapeutics is in search of a Senior Regulatory Strategy Manager to join our dynamic team. This pivotal role is designed for an innovative and proactive regulatory professional who can foresee and tackle the complexities associated with securing market authorization for messenger RNA therapeutics, a groundbreaking class of medicines.

Key Responsibilities:

  • Provide comprehensive regulatory guidance for Oncology projects, including the management of submissions and approvals for INDs, marketing applications, and various regulatory documents.
  • Develop and refine content, structure, and accountability for regulatory submissions and related amendments, including but not limited to FDA meeting requests, briefing documents, orphan drug designations, and pediatric plans.
  • Collaborate with regulatory strategists and project teams to formulate and implement regulatory strategies throughout the clinical development lifecycle.
  • Coordinate all aspects of regulatory submissions pertinent to assigned projects, ensuring compliance with relevant regulations.
  • Engage with regulatory agencies as necessary to facilitate project advancement.
  • Contribute to the establishment and execution of clinical and pre-clinical regulatory strategies for projects at all development stages.
  • Support the maintenance of the Core Data Sheet and participate in global labeling team discussions.
  • Demonstrate the ability to work autonomously as well as collaboratively within teams to achieve collective objectives.

Qualifications:

  • A Bachelor's degree in a scientific, engineering, or healthcare discipline is required; advanced degrees such as a Master's, PharmD, or PhD are preferred.
  • A minimum of 5 years of experience in the pharmaceutical sector is preferred, with at least 3 years focused on regulatory strategy or relevant training.
  • Experience in Oncology is highly desirable.
  • In-depth knowledge of current US and EU regulatory frameworks.
  • Proficient in CTD format and content for regulatory submissions.
  • Exceptional verbal and written communication skills.
  • Experience in conducting gap analyses and developing competitive regulatory strategies.
  • Comprehensive understanding of regulatory procedures and legislation related to drug development and product registration.
  • Strong organizational abilities, including effective workload prioritization.
  • Proven experience in preparing significant regulatory submissions and supportive amendments.
  • Ability to interpret regulations, guidelines, and policy statements effectively.
  • Experience with products in development, particularly concerning clinical and pre-clinical regulatory elements.

About Moderna:

Since its inception, Moderna has aimed to establish a leading mRNA technology platform, revolutionizing the creation and delivery of medicines. We are committed to fostering a culture of innovation and collaboration, where every team member plays a crucial role in our mission to transform healthcare.

We value diversity and inclusion, recognizing that a wide range of experiences and perspectives enhances our ability to serve our patients and communities effectively.

Moderna is an equal opportunity employer, dedicated to creating a workplace that reflects the diversity of the communities we serve.