Director / Senior Director, Regulatory Affairs Strategy

Job Summary:

The Director / Sr. Director, Regulatory Affairs Strategy will be responsible for developing and implementing regulatory affairs strategy to support preclinical and clinical development programs leading to successful registration and life-cycle management of Tevogen’s T cell therapy products. 

Key Responsibilities:

• Develop and implement regulatory strategies to meet business objectives for Tevogen’s development projects
• Ensures that the regulatory strategy for assigned projects is consistent with the Tevogen’s business objectives and have been negotiated with relevant health authorities as appropriate
• Leads the drafting and submission of regulatory dossiers as required to support global clinical trial applications and marketing authorizations (including initial INDs, IND amendments, responses to requests for information, NDAs and MAAs etc)
• Supports agency interactions and the preparation of briefing materials
• Leads the strategy, preparation and submission of other regulatory applications as required, such as ODDs, PIPs, Fast Track/BTD
• Conducts regulatory risk assessments on issues that arise in development teams
• Leads or supports the generation of SOPs related to regulatory affairs
• Works with external regulatory consultants/CRO’s as appropriate
• Ensures regulatory documents are appropriately published and reviewed prior to submission
• Ability to meet deadlines for developmental milestones
• Other duties as assigned

Preferred Qualifications:

• Background in Immunology, Biotechnology, and Cell Biology
• Minimum of 6 years of regulatory experience in the biopharmaceutical industry
• Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to biologics and cell therapy
• Demonstrated leadership and success in management of regulatory activities with a proven track record of effective collaboration with regulatory agencies
• Direct experience of leading regulatory authority meetings in different phases of drug development
• Excellent interpersonal, verbal, and written communication skills
• Ability to function efficiently and independently in a changing environment
• Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description

Education:

• Bachelor’s degree in a scientific discipline required