REGULATORY AFFAIRS CONSULTANT

Summary:

Seeking a Regulatory Affairs Consultant to join our team and provide regulatory leadership in support of the development programs.

This position supports all regulatory affairs activities for the company’s products, including but not limited to researching, collecting, and summarizing regulatory intelligence, performing regulatory assessments, participation in project teams, providing input for regulatory submissions, and managing the compilation and review of all submissions for completeness and quality.  This includes the development and implementation of biotherapeutic regulatory strategy, ensuring timely preparation, review, and submission of documents to regulatory authorities.

Responsibilities:

• Develop and implement regulatory strategy for assigned programs
• Represent the regulatory function on cross-functional in-house teams
• Serve as a resource to team members for regulatory requirements and processes for products and therapies from the pre-clinical stage through full life cycle management
• Prepare and manage submissions to regulatory authorities including FDA, EMA and other authorities to support the approval of applications
• Ensure compliance with regulatory requirements and ensure regulatory documents are complete, accurate and meet deadlines
• Prepare meeting requests, briefing packages, and prepare teams for meetings with regulatory authorities
• Interface with regulatory authorities, present development position to achieve company objectives and goals

• While primarily focused on clinical regulatory activities, CMC regulatory support may also be needed
• Takes ownership of a given assignments, proactively consulting other project team members and other department representatives for information or guidance, as necessary
• Working knowledge of manufacturing research and development. CMC regulatory experience, and/or knowledge of cellular therapies manufacturing, and quality development would be an advantage
• Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
• Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a start-up environment

Education and Qualifications:

• Bachelor’s degree (MS, PhD, PharmD preferred) in Life Sciences field
• 10+ years of regulatory affairs experience in the biopharmaceutical, medical device industry
• Extensive knowledge of regulatory requirements
• Experience with cell or gene therapies or medical device/combo products strongly preferred
• Experience in a regulatory leadership role, providing strategic advice on integrated regulatory development plans and executing the regulatory strategy
• Strong FDA experience in the preparation and submission of regulatory documents (IND/CTA/NDA/MAA)
• Must be knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS/MAA), including electronic document submissions
• Strong interpersonal and communication skills, proven negotiation skills