This clinical-stage biotech company is enabling cures by targeting mast cells and stem cells. They are seeking a Senior Regulatory Affairs Consultant who can develop and lead Regulatory strategies until the company can hire a new SVP/VP of Regulatory. This is a remote, part-time engagement (approximately 10-20 hours per week) for about 2-3 months or until the FTE role is filled.
Responsibilities:
- Provide strategic direction to all Regulatory until a new VP/Head of Regulatory Affairs can be hired.
- Guide and/or lead regulatory agency interactions, including communications and meetings.
- Provide regulatory leadership and support to project/program teams and Senior Management for all aspects of the development program.
- Effectively communicate requirements and compliance obligations under laws, regulations, and guidance in the US and around the world.
- Direct and negotiate submissions (IND, CTA, NDA, MAA etc.) and approvals with Regulatory authorities.
- Strategize, lead, write and/or supervise the development of and submission of documents/dossiers to regulatory agencies to achieve development goals. Ensure on-time, high-quality and regulatory–compliant submissions.
- Contribute to the creation of the overall product development strategy and manage the development, monitoring and delivery of regulatory project plans throughout the life cycle.
Qualifications:
- Advanced degree such as MS, PharmD, or PhD preferred.
- A minimum of 15 years of Regulatory Affairs experience in the biopharmaceutical industry.
- Strong understanding of the drug development process; Experience in biologics development and regulations is highly preferred.
- A track record of successful interaction with FDA and other regulatory agencies, as demonstrated by timely submissions and approvals of biological/pharmaceutical/biotech compounds.
- Experience supporting both early and late phase development, including development and filing of associated regulatory submissions.
- Ability to review, understand and explain the regulations and guidance documents to guide project teams.
- Proven success in communicating to and negotiating with FDA and global health authorities and managing clinical trial applications in several geographies around the world.
- Must have experience working with EU/EMA.
- Ability to drive meetings with various stakeholders including senior management, regulatory agencies, investors, expert advisors, collaborators and project teams.
- Must have previous Regulatory team leadership experience.
- Outstanding written, oral, organizational, and interpersonal skills are required for this highly collaborative role.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.