- Leads and supports preparation, submission, and maintenance of regulatory applications, including initial clinical trial applications, routine amendments, briefing documents, annual reports, IND safety reports, and responses to health authority inquiries
- Interacts with the CMC, Clinical Development, Clinical Operations and other functions to ensure optimal execution of the agreed regulatory strategy for investigational medicinal products.
- Participates in cross-functional teams, providing regulatory feedback and support.
- Assists in project-related interactions with regulatory consultants and contract research organizations.
- Directs and submits product prioritization designation requests, e.g. orphan drug, rare pediatric designation, breakthrough therapy, fast track, accelerated approval, PRIME, etc., in US and EU, respectively
- Works with technical and medical writers to manage document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables.
- Assists and attends regulatory authority meetings.
- Coordinates with external publishing vendors to ensure timely and accurate submissions
- Maintains archive and tracking of ongoing submissions.
- Completes other responsibilities as assigned and/or agreed upon.
- Maintains up-to-date knowledge of the regulatory landscape, regulations, and guidelines
- Degree in biological or life sciences, pharmacy or medicine (or international equivalent). An advanced degree is desirable. A minimum of 10 years in the pharmaceutical industry or relevant work experience and a minimum of 6 years in Regulatory Affairs.
- Experience in the preparation and submission of regulatory documentation to support Agency review/approval procedures, post approval activities, and a good breadth of understanding of FDA regulations (EU and International is a plus).
- Experience representing Regulatory Affairs on cross-functional teams is desirable.
- Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
- Excellent communication skills both in writing and verbally.
Knowledge, Skills and Abilities:
- Ability to work under minimal supervision of Regulatory Affairs professionals but following detailed instruction with well-defined procedures.
- Knowledge and experience relating to clinical trials would be desirable.
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