Vice President, Regulatory Affairs
Utilizing detailed, in-depth understanding of drug regulations, leads the development of regulatory strategies, interprets regulations, and provides regulatory guidance to project teams. Plans and prepares complex regulatory submission documents for all regulatory filings (US and exUS) and serves as the liaison between the company and the regulatory agencies. Implements departmental strategies and policies.
Principal Duties and Responsibilities:
- Provide regulatory oversight and guidance to the research & development strategies, as well as to clinical, manufacturing and business decisions facing the Company.
- Ensure TRACON complies with all appropriate regulations and guidelines (e.g. FDA, ICH, EMEA)
- Manage IND filings, including anticipated BLA filing, and FDA correspondence
- Anticipate changes in the regulatory environment and approval requirements to maximize the likelihood of drug approvals.
- Serve as a respected corporate liaison during all interactions with regulators and regulatory agencies.
- Continue positive communications and rigorous interaction with the FDA and other regulatory agencies to ensure regulatory concurrence with corporate development strategies.
- Ensure preclinical, clinical and manufacturing activities meet all relevant requirements and guidelines.
- Independently plan, prepare and review complex regulatory documents for product approvals. Independently resolve submission problem areas.
- Prepare documentation that is complete, accurate, and on time. Convey information on global regulatory team timelines and status to supervisor.
- Build an organizational framework that improves the probability of success for all regulatory activities through enhanced teamwork and collaboration
- Participate on all major project teams
- Provide guidance regarding compliance issues. Establish operational standards within the department and take necessary steps to ensure consistent and timely submission of regulatory documents.
- Represent the Company externally in scientific, financial and business development communities. and
- Provide budget input and review support.
- Maintain risk assessment program company-wide.
- Review labeling and packaging components to ensure accuracy and compliance with governmental regulations.
- Work with team to resolve complex project issues.
- Select and hire qualified consultants and contract vendors as needed.
- Bachelor’s degree required and advanced degree (Master’s or PhD) preferred
- Minimum of 15 years in the biotechnology or pharmaceutical industry, with at least ten years of regulatory and managerial/supervisory experience.
- Demonstrated understanding of all applicable regulations and guidelines governing drug development including ability to apply these to overall strategic drug development.
- Excellent working knowledge of FDA and ICH guidelines
- Excellent leadership, interpersonal and communication skills. Works efficiently with others to accomplish goals and resolve problems. Encourages cooperation, collaboration, and co-ownership of processes.
- Experienced self-motivated individual with a record of achievement in submitting successful IND(s) and BLA(s).
- Experience dealing with compliance issues addressed by health authorities. Expertise in the areas of GCPs, cGMPs and GLPs.
- Have developed and maintained excellent working relationships with global health authorities.
- A history of developing a culture of teamwork, collaboration and communication.
- Experience working with project teams and with the ability to communicate with experienced regulators in the various governmental agencies.
- High energy level and a winning approach with the proven ability to hire, lead, manage and develop professional-level subordinates and to adhere to high ethical standards.
- Good conflict resolution and problem solving skills.
- Strong interpersonal skills and matrix management skills.