The Vice President, Global Regulatory Affairs (VP Global RA) reports directly to the Senior Vice President, Regulatory Affairs and Quality Assuranve (SVP RAQA). This individual will have accountability for the global regulatory department and will lead a team of regulatory professionals as well as as be responsible for the management of key regulatory processes including global regulatory operations, strategy, labeling, and technical writing. The VP Global RA may also be involved in crossfunctional projects outside the core area of responsibility.
- Accountable to lead the global regulatory strategy for the Companys products (approved and pipeline).
- Provide counsel, training, and interpretation of global regulatory authorities feedback, policies and guidelines.
- Have oversight and accountability of the Companys interactions with global regulatory authorities.
- Interpret, plan, and communicate requirements to ensure global registration applications are adequately & timely managed
- Oversight and accountability for key regulatory process such as, technical writing and global regulatory operations (e.g, management of regulatory teams across various countries).
- Lead and represent the Company before regulatory authorities together with regulatory professionals and subject matter experts.
- Interact with other functions leaders and project teams in the preparation, review, and completion of global regulatory strategies and required documentation to support regulatory submissions.
- Responsible for ensuring positive and proactive communications with all applicable stakeholders and Development Teams keeping them informed of regulatory statuses and significant regulatory issues, communicating risks and ensuring mitigations/contingencies.
- Able to oversee all project related regulatory strategy with all global project teams.
- Assure compliance with project team timelines and milestones for global regulatory deliverables.
- Oversee and accountable for the effective planning, organizing, and conduct of formal meetings with regulatory agencies including advisory committee meetings, oral explanations and other scientific and development meetings.
- On behalf of the Company represent the Leadership Team with an executive level presence when interacting with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of studies, CMC aspects, etc.
- Accountable for directly building and maintaining key external relationships across regulatory agencies and key stakeholders.
- Responsible for developing and cultivating a high performing regulatory team focused on accountability and meeting and exceeding expectations.
- Accountable for the Department/Functional Budget and Budget Management.
- BS, MS, or Ph.D (desirable) in a Life Sciences discipline or equivalent.
- Minimum of 15 years of experience in regulatory affairs and a minimum of 10 years of progressive leadership experience in the Medical Device or IVD industry.
- Strong leadership skills, with a minimum of 10 years experience in managing a team
- Able to think on your feet type- with great personality and self-driven to achieve success.
- Must be a go-getter and a doer and able to handle a face-paced, real-time fast-changing work environment.
- Extensive experience in cGMP and other Regulatory (CMC, preclinical) compliance requirements.
- Proven experience and success record with global regulatory interactions and affairs including at minimum USA, EU MDR/IVDR, ISO 13485/MDSAP, and JAPAC.
- Experienced team player with strong management and interpersonal skills to quickly gain confidence both with internal stakeholders and externally among regulatory agencies. Highly influential.
- An individual who can influence direction of complex regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
- Technical expertise to be a credible interface to all development and business partners (CMC, R&D, preclinical, marketing, legal, etc.).
- Strong understanding of the drug development process is a plus
- Familiarity with womens health product development preferred