Description:

The Director of Regulatory Affairs is responsible for developing and implementing global regulatory strategies to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. This position will manage compounds through all phases of development, post-approval and life-cycle of the product.

Job Responsibilities:

• Provides support for all phases of the product development in the assigned portfolio and interfaces with R&D, clinical operations, project management, marketing, and regulatory colleagues.
• Develops regulatory strategies for global filings knowing life cycle of drug product from R&D through marketing and is able to interpret and apply local regulations and guidance’s to the life cycle of a drug product. This includes review of changes in existing products to determine need for new/revised submissions or document reason for no submission
• Prepares document packages for regulatory submissions from all areas of company. This includes initial submission to Health Authorities (HA), preparation of responses to questions from HA as well as reviewing them critically.
• Manage timelines in cooperation with project management on assigned projects.
• When needed, author scientific writing and review of IND, CTA, BLA/MAA, and their amendments and evaluate conformance with the regulatory requirements.
• Extensive knowledge of US, EU and ICH CMC regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues.

Experience and Background:

• BS/BA Biochemistry, Biology or Pharmaceutical Science, advanced degree preferred with at least at least 8-10 years experience in the pharmaceutical industry and at least 3 of these years in a CMC regulatory function with biotech products; global responsibilities preferred.
• CBER experience required.
• Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas.
• Has medical/scientific understanding of clinical trials and drug development.
• Demonstrated experience in working with multiple stakeholders, demonstrated success in negotiation skills, strategic thinking, strong verbal and written communication, leadership and be a credible business partner within the organization.

To apply for a position at Inspiration, please email your cover letter and CV to careers@inspirationbio.com.  Please note within the subject of the email the position you are interested in.