4 months ago
About the job
A clinical-stage biopharmaceutical company developing a novel pipeline of combination therapies for musculoskeletal infections and their consequences. Our lead investigational candidate,was granted Orphan Disease, FastTrack and Qualified Infectious Disease Product designations and is conducting Phase 2 comparative studies in PJI. With a robust pipeline of additional indications and therapeutic candidates, we anticipate rapid and sustained growth for the foreseeable future.
The VP Regulatory Affairs is responsible for strategic planning, execution and maintenance of all regulatory submissions and approvals using the 505(b)(2) regulatory pathway. As leader of the Regulatory function, this person will be a critical member of the company leadership team, reporting directly to the CEO.
· Lead the regulatory function and enable successful product development, approvals and life-cycle management.
· Establish the long-term regulatory strategy and plan in accordance with an established road-map and with an expectation to scale-up efficiently and rapidly.
· Manage and execute pre-IND, IND and NDA submissions for combination product approval.
· Manage and execute 510(k) submissions for stand-alone devices developed by the company.
· Develop and execute new Orphan Drug, Fast Track, Priority Review, Rolling Review, QIDP, LPAD, BTT, Accelerated Approval and other requests for special FDA designations and expedited review.
· Manage and execute regulatory submissions in international markets based on U.S. clinical trials.
· Ensure regulatory compliance with pre- and post-approval filing and reporting requirements, including review of all product labeling.
· Manage regulatory compliance and reporting of all clinical trials.
· Provide regulatory due diligence assessments of new business opportunities.
· Support executive management on regulatory issues with investors and business partners.
· Monitor and advise executive management on changes in regulations and their impact on the company.
· Hire and manage regulatory consultants and/or staff to complete regulatory objectives.
Education, Experience and Skills
· Minimum B.S. degree, advanced degree preferred, degree in life sciences preferred
· Minimum 10 years pharmaceutical regulatory experience, 505(b)(2) experience preferred
· Experience with FDA special designations or expedited programs for NDA approval
· Experience with combination products or medical devices preferred, particularly in the orthopedic industry, but not required
· Knowledge of global regulatory requirements for drugs and medical devices, international drug approval experience preferred
· Hands-on professional, able to execute on detailed submissions with minimal support from a team until a larger team is needed
· Excellent organizational and communication skills
· Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, clinical, regulatory and executive management teams
· Experience in directly interfacing with relevant regulatory authorities
· Experience in interpretation of regulations, guidelines, policy statements, etc.
· Willing and able to travel as needed (typically 10%) #LI- AM2