Title: Manager/Senior Manager, Regulatory Affairs Strategy
One of the best/award winning San Diego biopharma in the Neurology space is looking to bring on two essential Regulatory hires to contribute to regulatory strategy and prepare regulatory submissions. The company has a deep pipeline of 6 different products in the clinic, in addition to their 2 commercialized products. A company of this girth will not only allow for the mentorship from truly talented professionals, but also career development where you will contribute to all functions of Regulatory.
We are looking for a detail oriented and personable Regulatory Affairs Manager/Senior Manager who has a working knowledge of FDA and ICH regulations. This position will require contributions to global and domestic strategy as well as authoring, planning, and meeting deadlines to all Regulatory submissions. We are also looking for an individual who has experience working with CMC sections of submissions. Experience in Neurology is a plus.
- Ensure regulatory compliance to FDA and international regulations
- Providing global regulatory strategy to contribute to INDs, CTAs, briefing documents, and maintenance of development, and other Regulatory documents
- Develop essential timelines for Regulatory submissions
- Manager products and timelines
- Report to the Director of Regulatory Affairs
- Work cross-functionally
- Provide knowledge of CMC, Clinical, Non-clinical activities across various development programs
- Participate as a core member of the Regulatory Affairs team
- Work hands-on in a dynamic fast-paced environment
Experience and Qualifications
- Minimum of 5+ years direct related professional experience with a minimum of 3+ years within Regulatory Affairs
- Leadership experience of 2+ years is desired
- Significant knowledge and understanding of ICH and FDA guidelines
- Ability to work independently and take direction from a mentor
- Interpret Regulatory Affairs documents, submissions, and reports
- Excellent verbal and written communication skills
- Minimum of bachelor's degree or above in a life sciences field from an accredited college or university required
If you are interested in the Manager/Senior Manager of Regulatory Affairs Strategy role, do not hesitate to apply!
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