As a Senior/Executive Director in Regulatory Affairs, CMC, focusing on diagnostics and medical devices, you will be responsible for establishing the overall regulatory strategy for contemporaneous development of devices and diagnostics for products during clinical development and life cycle management. In this role you will serve to develop a regulatory strategy that is appropriate for clinical development of the product by interfacing with key functional areas and teams across BioMarin. This will involve a close collaboration with various product teams and functions to set up procedures for working across disciplines, and to build a framework that is consistent with the current global regulatory requirements in this rapidly changing environment.
In this leadership role, you will be responsible for a functional area within Regulatory Affairs that is strategic and that has corporate-wide impact. This role will serve as a primary point of contact to teams and as a key contributor to governance decisions for strategic alignment and direction. This role will support teams in early and late-stage clinical development to advance the product through critical milestones and regulatory activities that lead to registration in major territories. You will actively build strong relationships across stakeholders, management, and with contract organizations. This role will also serve to interface with contract labs and manufactures of medical devices and diagnostics to align strategies and to serve as a key regulatory lead for stakeholder alignment.
- Able to effectively collaborate, negotiate, and influence strategic alignment across teams and senior level executives.
- Able to constructively facilitate complex decision making among stakeholders and senior leaders in an area of regulatory that is complex and evolving.
- Advise and guide the Regulatory strategy development, Health Authority interactions, and submission activities
- Closely collaborate and participate on technical BioMarin Advisory Boards, Governance, and Steering Committees, as necessary
- Participate in global strategic leadership meetings and forums representing Regulatory Affairs perspective related to medical devices and diagnostics.
- Cross-functional leadership – advocate, collaborate, and build relationships across key stakeholders in Development, Research, Technical Operations, and with contract operations responsible for manufacture of medical devices and diagnostics.
- Mentor and guide Regulatory staff and teams working across all product modalities
- Critically review and provide input to regulatory strategy documents and regulatory submissions, including clinical trial applications (IND’s, CTA’s, etc.) and meeting briefing documents, and market applications.
- Partner closely with the Regulatory Policy group and support the BioMarin position to influence and guide external regulatory policy and changes in regulations, including taking part in the commenting process on regional regulatory guidance documents for medical devices and diagnostics used for all product modalities, including advanced therapeutics.
- Advocate for BioMarin by building strong relationships with Health Authorities and other external stakeholders as required to facilitate sound decision-making.
- Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
- May have presence on external regulatory committees/trade associations
EDUCATION AND EXPERIENCE
- Degree in health or life sciences, Ph.D. Preferred.
- Significant experience with registration of Medical Devices and Diagnostics (>20 years); Knowledge of the regulatory framework for medical devices and diagnostics in all major markets, and able to apply strategic experience and solution to clinic development and marketing authorizations worldwide.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.