This client is a clinical-stage biopharmaceutical company focused on the discovery and development of transformational therapies for patients with serious, rare diseases. They are seeking a Regulatory Affairs Associate Director or Director to contribute to global regulatory strategy and lead regulatory activities for multiple rare disease development programs. You will interact directly with the FDA and other health authorities, while also working closely with cross-functional teams. Now is an exciting time to join this growing company and make an immediate impact on the lives of patients!
- Develop robust, global regulatory strategies for assigned rare disease projects and adapt and/or maintain the regulatory strategy as needed.
- Provide ongoing regulatory guidance to project teams.
- Interact directly with FDA and other health authorities and ensure that interactions with regulators are properly communicated to the development team.
- Develop submission plans and timelines in accordance with project goals.
- Lead cross-functional efforts to deliver high quality submissions for INDs, CTA, and Orphan Drug Applications.
- Manage submission development including the authoring of content as applicable and/or working with subject matter experts in content development.
- Triage and coordinate responses to questions from regulatory authorities.
- Contribute to initiatives to improve processes within the Regulatory department.
- Keep abreast of regulatory guidance and technical/scientific developments relevant to projects.
Knowledge and Skills:
- BA/BS degree in life sciences, MS preferred
- Eight years of industry experience with five or more years of experience in clinical regulatory affairs for pharmaceutical or biologic product development.
- Experience as primary regulatory author for IND and CTA documents. Experience working on a BLA, NDA, or MAA preferred.
- Rare/orphan disease experience required. Experience with CNS/neurology therapeutic area desired.
- Must be well-versed in regulatory strategy, and regulatory writing.
- Experience working directly with the FDA required. Global experience a plus.
- Knowledgeable in ICH, FDA and EMA guidelines; knowledge of eCTD structure.
- Ability to work independently and thrive in a fast-paced environment.
- Must have excellent communication skills, attention to detail, and the ability to think creatively.
- Flexible team player with the ability to be a situational leader when required