Associate Director, CMC Regulatory Science

2 days ago

Hermitage, United Kingdom Moderna Therapeutics Full time
Senior Manager, CMC Regulatory Science - UK

About the Role:
Moderna Therapeutics is seeking a highly skilled Senior Manager, CMC Regulatory Science to join our team in the UK. As a key member of our regulatory team, you will be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, as well as governing the CMC submissions and regulatory compliance support for the development of mRNA products made in the UK and from other origins.

Key Responsibilities:

  1. Develop and implement effective CMC regulatory strategies for UK and worldwide submissions.
  2. Provide expert guidance on regulatory CMC aspects of product development, including local regulatory considerations.
  3. Ensure submission-readiness of documents, conforming to health authority guidelines.
  4. Lead Regulatory CMC discussions and interactions with MHRA to facilitate the review and approval process.
  5. Develop and maintain regulatory processes to support CMC components of regulatory submissions.

Requirements:

  1. BSc in life science or relevant scientific field (e.g., Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering).
  2. Graduate degree and/or post-graduate certificate in a relevant discipline preferred.
  3. 8+ years of experience in the pharmaceutical/biotech industry, with substantial experience in Biologics-focused Regulatory CMC.
  4. Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases).
  5. Strong knowledge of current UK medicines regulations (especially variations); US, EU, APAC and ROW experience an asset.
  6. Strong knowledge of cGMP.
  7. Experience with eCTD format and content regulatory filings.
  8. Use of the VEEVA platform for the authoring and approval of documentation would be an advantage.
  9. Exceptional written and oral communication skills.
  10. Good influencing, negotiation, and relationship management skills.
  11. Demonstrated ability to develop effective regulatory CMC strategies that align to clinical considerations and commercial objectives.
  12. Ability to work at a high level in a fast-paced, dynamic environment.

What We Offer:

  1. Quality healthcare and insurance benefits.
  2. Lifestyle Spending Accounts to create your own pathway to well-being.
  3. Free premium access to fitness, nutrition, and mindfulness classes.
  4. Family planning and adoption benefits.
  5. Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown.
  6. Educational resources.
  7. Savings and investments.
  8. Location-specific perks and extras

About Moderna Therapeutics:

Moderna Therapeutics is a pioneering biotechnology company that is revolutionizing medicine through mRNA technology. We are committed to advancing the technological frontier of mRNA medicines and making a significant impact on patients' lives worldwide.

We are a smoke-free, alcohol-free and drug-free work environment.

We are an equal opportunity employer and welcome applications from diverse candidates.

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