Senior Director, Regulatory Affairs
The Regulatory Manager will support the preparation, quality check, delivery and archiving of regulatory submissions. Participates in regulatory strategy, submission preparation, and assists in the maintenance of a quality assurance system to support activities related to the Company’s products.
Essential Duties and Responsibilities
- Collection, preparation and assembly of documentation for submission to FDA and international regulatory authorities (e.g., IND, IMPD, CTA, NDA/BLA, Annual Reports, and other maintenance submissions).
- Coordination of regulatory meetings, including development of briefing documents and conduct of rehearsals.
- Provide regulatory guidance to assigned project teams.
- Lead working groups responsible for development of regulatory submissions; interact with other team members to ensure the timely preparation and receipt of information required for regulatory submissions.
- Interact with internal and external partners and consultants as necessary to support efficient and effective development.
- Understand and identify potential regulatory risks and implications and communicate effectively to working groups and senior management.
- Interact with FDA and other Regulatory Authorities on assigned projects as appropriate.
- Support reviewers and authors to understanding eCTD principles and complete compliant regulatory documents.
- Assist Quality Assurance in the organization and archiving of manufacturing, quality control and quality assurance documents, including the maintenance of the document control system.
Education and Experience
- Scientific background (minimum BS degree or equivalent in the life sciences) with at least 5 years of experience in regulatory affairs.
- Excellent oral and written communication skills.
- Thorough understanding of current and evolving FDA, ICH and other appropriate regulations and guidance.
- Demonstrated experience resolving domestic and international regulatory issues (Must have some experience interacting with FDA either in written format, teleconference or in person).
- Thorough current knowledge of eCTD format and regulatory submission requirements.
- Exceptional attention to detail, organization skills, ability to prioritize and multi-task, while being flexible as priorities change.
- Ability to work individually and independently, within a multi-disciplinary team, and with external partners and vendors. Has a customer service approach and is solution oriented.
- Preference for previous experience with biologics and/or oncology drug development.
- Proficiency in the use of MS Word, PowerPoint, Project; experience with Adobe Acrobat Professional; experience with electronic publishing systems preferred.