Manager Regulatory Affairs
My client is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye. They are looking for a Manager of Regulatory Affairs to thrive in their extremely collaborative, science driven company. In this role, you will have immense opportunity for growth and responsibility as you will be working with Regulatory management and project teams to identify and execute regulatory strategies. You will have the ability to work in an environment where you can make an immediate impact and hit the ground running!
Responsibilities:
- Lead the development, documentation, and implementation of regulatory strategies for new technologies and product modifications
- Collaborate with R&D to determine and execute pre-clinical test plans in support of regulatory submissions
- Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
- In coordination with regulatory management, lead the development, preparation and maintenance of US pharmaceutical submissions such as NDAs, INDs, meeting requests, briefing packages and applicable supplements, annual reports and periodic reports
Knowledge and Skills:
- Minimum BS in a scientific and/or engineering field required; advanced degree preferred
- Minimum 6 years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 3 years in CMC or Clinical Regulatory environment
- Must have knowledge of global regulatory guidelines and requirements
- Demonstrated experience in preparing NDA and IND, submissions for FDA; PMA, IDE and 510(k) submission experience desired
- Strong knowledge of eCTD elements and structure and regulatory writing skills
- Must have analytical skills, be detailed oriented and have good interpersonal skills