Job Description

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Develop and execute global regulatory strategies for one or more programs.
• Will be the regulatory lead for project teams and sub-teams for one or more programs.
• Lead the preparation, submission, and maintenance of regulatory filings (INDs, NDAs, BLAs, MAAs, etc.).
• Serve as the primary regulatory contact with health authorities, including the FDA, EMA, MHRA and other global regulatory agencies for assigned programs.
• Provide regulatory guidance and support to cross-functional teams, including Clinical, Therapeutic Discovery, and CMC teams.
• Monitor and interpret regulatory requirements and trends to ensure compliance and to inform strategic planning.
• Manage regulatory timelines and ensure timely submission of regulatory documents.
• Lead regulatory agency meetings and negotiations.
• Own the preparation of regulatory documents, including briefing packages, responses to health authority queries, and labeling.
• Ensure that all regulatory activities are conducted in accordance with applicable regulations, guidelines, and company policies.
• Other duties as deemed necessary.
• Travel up to 25%

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• BS degree in life sciences or a related field is required. Advanced degree in life sciences (MS, PhD, PharmD, MD, or equivalent) preferred.
• Minimum of 10 years of experience in regulatory affairs within the biotechnology and biopharmaceutical industries and working knowledge of the development of biologics targeted for the treatment of cancer.
• Proven track record of successful regulatory submissions and approvals, alongside successful direct interaction with global regulatory agencies (FDA, EMA MHRA and others).
• In-depth knowledge of global regulatory requirements and guidelines is required.
• Strong leadership and project management skills.
• Excellent written and verbal communication skills.
• Ability to work effectively in a fast-paced, dynamic environment.
• Strong analytical and problem-solving abilities.
• Ability to build and maintain effective working relationships with internal and external stakeholders.