Regulatory Affairs Senior Manager-Director
Company Summary:
My client is a growing leader in developing breakthrough protein therapeutics for Companion Animal Health. They are looking to add a Senior Manager-Director of Regulatory Affairs to support their growing pipeline of animal health products! This role will be fully onsite in Beverly, MA and they are able to help out with relocation.
The Regulatory Affairs Senior Manager-Director will be responsible for:
- Representing Regulatory Affairs activities among cross-functional project teams, functioning as primary contact on Regulatory CMC aspects of the projects with partner companies
- Collaboration with partner companies/consultants for the timely preparation, review and submission of documents to regulatory authorities
- Supporting cross-functional workstreams in support of IND/INAD applications, CTAs, and new biological applications (NDA/ANDA/BLA) and submissions
- Leading and/or co-authoring the preparation of information packages for Regulatory CMC submissions
The Regulatory Affairs Senior Manager-Director should have the following qualifications:
- 8+ years in the pharmaceutical industry and 5+ years of Regulatory experience with biologics (CMC and submissions)
- Has focused on regulatory submissions for veterinary biologics
- experience working with regulatory authorities such as FDA, FDA-CVM, USDA, and EMA across all phases of clinical development
