Our client is looking for a Manager of Regulatory Strategy Consultant for a 6+ month contract. They will be responsible for leading the company’s regulatory strategy development and planning related to development and commercial programs. This person will serve as the regulatory affairs leader to project teams for strategic planning related to achieving program milestones. They will oversee all regulatory applications (INDs and NDAs) with an emphasis on high-quality, timely submissions to Regulatory Agencies (primarily FDA). Submissions include IND’s and NDA’s (including 505(b)(2)), Annual Reports, amendments, Clinical Trial Applications, IND/NDA supplements, expedited program designation requests, and Study Plans. The client is fine with the individual coming from large pharma or small startups, but they need to understand the small startup environment and be hands on and heavily involved.
- Develops and leads strategic regulatory guidance and recommendations in support of company goals.
- Represents Regulatory Affairs within project teams and provides regulatory guidance to R&D, Clinical, Quality and Operations teams, as appropriate.
- Provides guidance to teams and peers to solve problems, achieve goals and meet company defined timelines.
- Provides clear communications of regulatory risk(s) associated with development activities.
- Must exercise judgment within defined procedures and policies to determine appropriate regulatory direction and communicate to peers.
- Serves as primary point of contact with FDA project manager for assigned projects.
- With minimal supervision, leads the preparation of responses to Health Authorities (US and Global).
- Liaises and orchestrates meetings with cross functional departments.
- Participates in product team meetings (development and marketed products).
- Ensures product team activities align with defined regulatory strategy
- Reviews technical documents for submission in new INDs, NDAs and provides guidance to the technical development groups.
- Authors and prepares original INDs/NDAs and amendments for submission to Regulatory Agencies.
- Manages day-to-day regulatory activities for assigned projects.
- Prepares both major and routine submissions to regulatory applications.
- Education: Minimum of Bachelor’s degree in a science-related discipline; RAC certification a plus.
- 5-8 years of relevant regulatory experience in pharmaceutical pharmaceutical/biotechnology experience, with extensive knowledge of all aspects of the drug development process.
- Strong knowledge of current US and global regulations/guidance.
- Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands from a variety of R&D, Clinical, QA, Marketing, and Operations team members.
- Proven ability to communicate with executive management and external thought leaders.
- Demonstrated identification of key regulatory risks.
- Must be well organized, detail-oriented, and can multi-task and manage changing priorities.
Remote: Manager of Regulatory Strategy Consultant (231373)