As the Vice President of Regulatory Affairs, you will work in partnership with the Head of Research & Development, Informatics and Policy as part of the leadership team for R&D, Informatics and Policy at PatientsLikeMe. Working cross-functionally with teams from Research & Policy, Project Management, User Interface, Business Development, Marketing & Communications, Patient Experience and other areas of the business. Primarily responsible for developing and executing regulatory plans for assigned programs, and as an internal and external facing regulatory expert, to be relied upon to articulate clear and compelling regulatory strategy, highlighting risks and opportunities. This is a newly created position at PatientsLikeMe intended for a forward looking, creative regulatory strategist committed to bringing his/her subject matter expertise to a new space.
Key Results Areas:
- Responsible for the development and execution of PLM’s regulatory program and strategy. Bringing your expertise in pharmaceutical, diagnostics (including complex and multibariate home-brews, LDTs, CDxs), devices or government regulatory compliance to a cutting edge industry.
- Serves as regulatory affairs executive to provide input on product development, research programs and patient engagement initiatives.
- Contributes to the development of Scientific Operational excellence across the company network in line with scientific strategy to focus on delivery of patient and commercial value for PLM.
- Serve as PLM’s regulatory expert in existing and emerging regulatory frameworks, global and regional requirements and trends, and interpretation and application to PLM’s product development.
- Establishes and maintains excellent relationships with regulatory agency personnel, and related industry stakeholders. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings.
- Reviews and approves technical data and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.
- Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.
- Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
- BA/BS degree in a Scientific or Engineering discipline. Graduate degree in a scientific discipline or other relevant graduate discipline or professional certification preferred.
- 10+ years of experience in Pharmaceutical, Diagnostics or Device industries and/or Government Regulatory space.
- 8+ years of experience in Regulatory strategy, ideally with Devices and Diagnostics
- Strong knowledge of current US and EU regulations
- Exceptional written and oral communication
- Experience with developing and implementing competitive and creative regulatory strategies
- Demonstrated track record in securing product approvals and maintaining a complex portfolio
- Experience dealing with broad range of stakeholders at all levels internal and external to the company
- Knowledge of and broad experience with regulatory procedures and legislation for product development and product registration– preferably from at least both US and EU
- Regulatory knowledge in a number of therapeutic areas
- Ability to lead and influence without authority
- Strong influencing and interpersonal skills including negotiation, managing meetings and group dynamics, ability to balance concerns of management with objectives of cross-functional teams.
- Able to galvanize a high-functioning environment and demonstrates emotional intelligence with individual personalities on a team
- Ability to recognize and capitalize upon the strengths of others
- Sensitivity to potentially conflicting agendas and ability to maintain objectivity in high-pressure situations
- Ability to work on multiple projects in parallel
- Interest in keeping abreast of key trends, companies and products in this sector