This is a Retained Search. Our client is a leading provider of non-opioid pain management and regenerative health solutions. Due to rapid growth, they are seeking a Vice President of Clinical Regulatory Affairs who can oversee the development and execution of clinical regulatory strategies for pharmaceutical drugs and medical devices, while building out a regulatory team. This individual will work closely with other senior executives and cross functional teams, and lead interactions with Health Authorities. With two marketed products, this company offers a passionate, small-company environment with the opportunity to wear many hats. Now is an exciting time to join this growing organization and help advance patient care.
Main Responsibilities:
- Develop and oversee execution of clinical regulatory affairs strategies for non-opioid pharmaceutical drugs and medical devices that will shorten approval times and improve product labeling in the US and other regions.
- Hire, train, and lead a team of clinical regulatory strategy professionals.
- Oversee the assembly of regulatory packages for IND, CTA, 510K, NDA, MAA or PMA submissions for new product development.
- In partnership with the VP of Regulatory CMC, oversee the management of marketed products, ensuring all reporting obligations are met, including PSURs, annual reports both to FDA and ex US regulatory bodies.
- Lead the regulatory function in strategizing and executing additional clinical trial programs for sNDAs for the company’s lead product.
- Work with partners in support of ex-US regulatory filings for products.
- Liaise with domestic and international regulatory agencies. Represent the company in regulatory health authority meetings. Assist with the preparation of Type B or C meeting documents, meeting requests, meeting packages, etc.
- Provide leadership on regulatory interactions with and presentations to regulatory agencies, customers, and partners.
- Work closely with members of the Regulatory Affairs, Clinical, Medical, Pharmacovigilance, Quality, Commercial and Legal/Compliance Departments.
- Oversight of PADERS, PSURs, DSURs and other reports to global regulatory authorities.
- Review and approval of Study Protocols, Clinical Study Reports, Statistical Analysis Plans, ISE, ISS, Module documents, and other documentation to be submitted to US and ex-US health authorities.
- Interpret regulatory guidance and provides recommendations to key stakeholders. Remain current and coach the regulatory group on regulatory guidance documents from the FDA, EMA, ICH, etc.
- Ensure adherence to relevant regulatory guidance and regulations, as well as company Standard Operating Procedures (SOPs).
- Act as a responsible company contact during inspections by the FDA and other authorities.
- Maintain team budget and resource planning.
Candidate Background:
- Bachelor’s degree in a scientific field. Advanced degree, such as PharmD, PhD, MS preferred.
- 15 years of industry experience with ten or more years of experience in Regulatory Affairs for pharmaceutical drugs.
- Regulatory experience with Medical Devices or Drug/Device combination products a plus.
- Previous experience hiring, leading and managing a Regulatory team.
- Demonstrated experience working directly with FDA and global Health Authorities (EMA, Health Canada, PMDA, etc)
- Strong knowledge of drug development and regulatory policy.
- Experience developing and leading regulatory strategies for NDAs and MAAs. 510Ks and/or PMA experience a plus but not required.
- Strong knowledge of biopharmaceutical industry Regulatory Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations.
- Expert knowledge of regulations and specific experience in new medical device development and the ability to support multiple commercial device products is a plus.
- Knowledge of clinical development, including responsibilities for successful management of development milestones and marketing authorization, meeting facilitation, and regulatory responses.
- Demonstrated knowledge of global (US, EU/UK and ICH) regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues.
Interpersonal, Leadership, and Soft Skills:
- Proven ability to hire, build, and lead a Regulatory team.
- Demonstrated strong negotiating and problem-solving skills.
- Proven ability to manage multiple projects, set priorities and meet deadlines.
- Ability to speak publically in front of diverse groups of all sizes including development and delivery of presentations to Agencies and Executive Teams.
- Proven ability to lead cross functional teams, serving as a strategic and tactical bridge between multiple areas.
- Must be comfortable in a small company environment. Able to be flexible and comfortable with ambiguity.
- Must have the capability to potentially succeed the SVP Regulatory Affairs.