Associate Director, Regulatory Affairs

Role Summary

The Associate Director of Regulatory Affairs will independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development organization. The candidate must have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback to management and project teams, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes.

Responsibilities

• Demonstrate leadership within the regulatory affairs department and cross-functionally to help develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior concerning risks.
• Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.
• Help drive operational decision making and planning within the department, overseeing workflow, assignments, and staff development with minimal direction.
• Utilize a comprehensive knowledge of regulations, regulatory authorities' guidance, and industry practices to support organizational objectives.
• Able to proactively identify risks and devise mitigation strategies.
• Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.
• Perform regulatory research to inform business strategy. Assess and communicate risks.
• Assure that there are no significant interruptions to the business due to regulatory compliance issues.
• Collaborates across the organization at all levels, across functional groups, and with executive management.
• Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations.

Qualifications

• Required: Bachelor's Degree in a relevant field, an advanced degree is desirable, with a minimum of 7 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 5 years in Regulatory Affairs.
• Required: Experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post-approval activities.
• Required: Experienced in representing Regulatory Affairs on cross-functional teams and presenting to senior management. Excellent communicator.
• Required: Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
• Required: Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance. Experience with EU CTR submissions preferred.
• Preferred: Direct experience with oncology drug development.
• Preferred: Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols.
• Preferred: Direct experience with FDA expedited programs.

Education

• Bachelor's Degree in a relevant field; advanced degree desirable.