This client is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. They are seeking a Regulatory Affairs Manager (or Senior Manager) who can provide regulatory support for their early- and late-stage programs. Serving as the right hand to the SVP of Regulatory, you will manage regulatory submissions and interact with health authorities. This role can be remote with some regular visits to the Boston-area office. With a unique scientific platform and their lead program going into Phase III this year, now is an exciting time to join this growing organization and help to get innovative new therapeutics approved!
Responsibilities:
- Lead and manage timely submission activities including the planning, authoring, editing, reviewing, coordination, and submission for regulatory filings (INDs, BLAs, etc)
- Provide regulatory guidance and share information to cross-functional project teams
- Prepare correspondence with regulatory agencies (meeting requests, briefing documents, responses to regulatory authorities, etc.)
- Provide operational and tactical guidance to cross-functional program teams, while ensuring compliance with applicable regulatory requirements.
- Support effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
- Participate in Health Authority meetings
- Participate in the development and optimization of processes and procedures relevant to the submissions including timelines
- Work collaboratively with internal stakeholders to ensure that regulatory standards and compliance are considered throughout the program lifecycle
- Continually monitor the regulatory environment to maintain expertise in regulatory principles, landscape changes, competitive products, and implications
- Perform regulatory intelligence as necessary
- Engage in continuous improvement initiatives for regulatory affairs processes and/or activities
Candidate Background:
- Bachelor’s degree in life sciences; advanced degree (PhD, MS, PharmD, MD) preferred.
- Five or more years of applicable Regulatory experience working in a biotechnology or pharmaceutical organization
- Clinical Regulatory experience for programs in development is required. Experience working in later-phase product development programs highly desired
- Prior experience with regulatory filings including INDs, CTAs, NDA, BLAs, supplements and amendments
- Regulatory experience with biologic programs desired but not required
- Experience in Regulatory CMC and non-clinical regulatory affairs is a plus.
- Strong working knowledge of the drug development process
- Good understanding of requirements, context, and content of regulatory submissions
- Demonstrated ability to understand and interpret regulatory requirements and translate this into concrete propositions
- Working knowledge of Agency regulations and industry standards pertaining to regulatory
- Excellent oral and written communication skills are required
- Ability to lead and manage projects to completion and experience working in project teams
- Strong interpersonal and organizational skills
- Must be comfortable in a small company environment. Must be flexible and comfortable with ambiguity.