215 First Street
Post Date: 04/19/2018
Job ID: 1909
Job Category: Clinical: Regulatory
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.