My client is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases.
The Vice President, Regulatory and Quality Assurance will join the executive management team and assist in the development and implementation of strategies, business plan, budget, and works plans to achieve company’s vision and mission. The position will provide leadership for all Regulatory and Quality activities to drive product development programs and ensure the Company’s ongoing compliance with regulatory mandates. Oversee the company’s regulatory activities and initiatives, assure the quality of products and processes, and ensure the highest integrity in regulatory and quality compliance. Will lead teams to strategize product development plans and advise department leaders of regulatory considerations in-light-of the Company’s goals and overseeing all aspects of submissions to regulatory authorities. Must be a dynamic leader with outstanding communication, strategic and collaboration skills, and will provide adept supportive leadership.
Specific Regulatory Responsibilities Include
- Serve as the primary corporate interface for all regulatory authorities, both within and outside the U.S.
- Identify required or advisable regulatory submissions, both within and outside the U.S. based on corporate objectives; establish timelines for preparing, reviewing, and finalizing submissions.
- Develop document templates to assist individual functional groups with responsibility for drafting substantive content; coordinating with multiple groups to maintain submission timelines, providing final review to ensure internal consistency, satisfaction of regulatory requirements, corporate objective(s), and overall “fitness for purpose”.
- Responsible for defining requirements for writing, editing, final review and approval of reports and regulatory submissions.
- Accountable for the accuracy of regulatory submissions, and communications with Regulatory Agencies.
- Participate in internal cross-functional group meetings and providing regulatory input in multiple areas, including clinical study design and endpoints; preclinical pharmacology and toxicology; and CMC.
- Responsible for organizational policies and standards to maintain corporate regulatory compliance and maintains responsibility for the implementation of such policies and procedures.
- Develop and implement a departmental budget that meets all corporate and regulatory goals and requirements.
- Review Final Study Reports, manufacturing process documentation, Investigator Brochures, Clinical Study Protocols, and clinical trial documentation for compliance with cGCPs, cGMPs, cGLPs and other regulations and guidelines.
- Communicate changing regulatory requirements with senior management throughout the company.
- Stay current with regulatory developments relevant to the Company’s programs.
- Advise senior management, including making recommendations regarding tactical and strategic considerations in the context of corporate goals and identifying changes and trends within regulatory bodies, both within and outside the U.S.
- Establish a network of relationships with key national and international regulators/regulatory agencies; interacts with key scientific, clinical research, marketing and commercial personnel internally and externally to ensure timely and accurate regulatory compliance.
- Defines and establishes regulatory strategies for product development efforts and works closely with research and clinical development.
- Ensures that CMC and clinical trial protocols are properly designed to comply with current regulatory guidelines.
- Accountable for timely adverse event reporting to regulatory activities.
- Perform other duties as required.
Desired Knowledge And Abilities
- Experience in all phases of regulatory submissions and interactions, including post-approval experience; international experience also required, along with direct contact and negotiation experience with the FDA.
- Rare disease experience a plus.
- Experience in leading the Quality function for a biopharmaceutical company and familiarity with GxPs.
- Experience with electronic filing and database management abilities.
- Experience with documentation systems and with document review and auditing.
- Excellent communication skills, team member that can work collaboratively with colleagues across all functions.
- Excellent analytical, presentation, writing, and computer skills are required.
- Comprehensive knowledge of current US and ex-US regulatory guidelines.
- Demonstrate excellent leadership and communication skills.
- Demonstrate strong organizational skills, including the ability to prioritize personal workload.
- Extensive supervisory experience and ability to guide, train, supervise and prioritize workload of direct reports.
- Senior managerial experience in a small company environment is desirable.
- Ability to work well in a deadline-driven environment.
- Capable of supporting multiple projects simultaneously.
Education And Experience
- Bachelor’s degree Life/Health Sciences; Master’s degree and/or Ph.D. a plus
- Minimum of 20 years of experience in pharmaceutical / biotech
- Minimum 15 years in a management role within Regulatory / Quality Assurance