Our client is seeking a Sr. Director, Regulatory Affairs. As a member of the program teams, they will provide strategic guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.
Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
Organize and manage regulatory meetings with health authorities.
Review materials for compliance with advertising and promotion regulations.
Perform regulatory strategic assessments for new product candidates and new indications.
Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority) or special status (e.g. Orphan).
Manage contract staff and vendors as needed to support regulatory activities.
Provide create and innovative solutions while being an advocate for compliance.
10-15 years of experience in Regulatory Affairs related to development of pharmaceuticals, CNS experience preferred
Bachelor of Science in a scientific discipline, MS or PhD preferred
Strong knowledge of eCTD elements and structure
Strong regulatory writing skills and use of Microsoft Word
Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
Strong team player that has a customer service approach and is solution oriented.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Possesses strong written and verbal communication skills.