Associate Director / Director CMC Regulatory Affairs

  •  

Boston, MA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 37 days ago

  by    Sam Murphy

A global company based in Boston are seeking a talented Regulatory profile to lead the CMC team to more success. The company have been growing steadily for the last two years and now have an amazing portfolio of vaccine products.

As Associate Director/Director CMC Regulatory Affairs you will be expected to serve as the global product leader. You will be a key member in the CMC regulatory strategy for one or more vaccine products.

This will include formulating and implementing global CMC regulatory strategies for the development of therapeutic vaccines. Leading CMC regulatory activities for assigned projects and coordinate all aspects of CMC regulatory submissions.

A deep knowledge and experience of Vaccines or Biologic CMC is needed for this opportunity. At least 5 years working within product development is essential to the position.

Primary Responsibilities

  • Develop and implement CMC Regulatory strategies for assigned projects and provide advice and strategic guidance to development teams.
  • Serves as the CMC regulatory lead on relevant project teams and sub teams.
  • Plans, manages, and executes all CMC regulatory activities for assets in various phases of development.
  • Establish, in collaboration with the CMC technical team, a harmonized set of CMC templates for global regulatory submissions which satisfy global regulatory requirements.
  • Serves as the Regulatory lead in Health Authority meetings and leads preparation of CMC activities for meetings with Health Authorities.
  • Interacts directly and indirectly with FDA and international Health Authorities, as necessary.
  • Interacts directly and indirectly with internal and external partners on CMC regulatory topics, as necessary.
  • Ensures line management and key stakeholders are apprised of ongoing developments.

Travel

• Some international travel may be required.

• Requires approximately 10% travel.

Salary

$138K - $225K