Position: Vice President, Regulatory Affairs and Quality
Position Level: Executive
Reports to: Chief Medical Officer
Overview of Position:
Responsible for all Regulatory Affairs and Quality matters within Equillium, which includes: providing strategic and operational leadership in these areas, notably in the development and execution of regulatory strategy and through leading interactions with global regulatory agencies. Additionally, this position will also be responsible for developing, implementing and promoting Equillium’s overall GxP quality management system and all GCP, GMP and GLP activities. The incumbent will develop, implement, prioritize, and communicate the company’s quality strategy and its quality programs, including quality assurance and total quality management throughout the organization.
As such, the Vice President, Regulatory Affairs and Quality plays a key role in enabling Equillium to achieve its business objectives, both in respect of existing products and in the identification, assessment, acquisition and development of new products.
Essential Duties & Responsibilities:
- Work closely with the executive leadership team, lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of Equillium’s products and product-candidates.
- Develop and implement operational plans to achieve the board-approved regulatory objectives.
- Build a stage-appropriate regulatory affairs team, hire appropriate leadership, and manage internal and external consultant team members.
- Serve as primary regulatory agency contact (with the FDA and at other agencies) to achieve company regulatory objectives, by fostering strong relationships and acting as a credible, reputable and effective advocate for Equillium.
- Serve as key point of contact in relation to managing and directing regulatory inspections.
- Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future Equillium products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
- Facilitate best strategy for clearance/approval of products in rest-of-world regions either by Equillium or by its partners/affiliates, and act as the senior regulatory contact for ongoing alliance management activities.
- Develop and design robust regulatory structures, processes and procedures and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy.
- Partner with and support clinical development, CMC, medical affairs, commercial and corporate activities, including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle.
- Support the Pharmacovigilance and Safety functions as an active member of the Executive Safety Governance and Review team.
- Provide the business development team with guidance and critical evaluation of potential product opportunities, in support of strategic partnering and licensing activities.
- Provide regulatory review and approval of product labelling, promotional claims and advertising to ensure compliance with corporate policy, and US and international laws and regulations.
- Direct long- and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.
- Build a stage-appropriate quality team, hire appropriate leadership, and manage internal and external consultant team members.
- Manage and implement Quality systems. Manage and oversee SOPs, policies, training and vendors and vendor qualification processes. As appropriate, implement and maintain a suitable software system to support quality systems related activities.
- Conduct ongoing review of quality and assessment metrics, including development of mitigation strategies as needed and communicate quality metrics to senior leadership on a regular basis.
- Work with clinical development, drug safety and regulatory affairs staff to ensure that all activities, whether performed by the sponsor or contract organization, are conducted in compliance with applicable GCP requirements.
- Work with technical operations and manufacturing staff to ensure that clinical supply and commercial manufacturing activities are conducted in compliance with applicable GMP requirements.
- Be responsible for the overall review of batch records and release of clinical trial material lots and products, and the review of incident/deviation reports and of change controls related to manufacturing/quality processes.
- Develop, implement and monitor compliance with quality agreements established with vendors and partners.
- Ensure that the company and all company sites, vendors and clinical trial sites are prepared, for inspection by regulatory authorities.
- Provide post-regulatory agency inspection support and follow-up as required.
- Perform or oversee internal and external audits, ensuring compliance with company policies, procedures and applicable regulations.
- Review and approve audit reports and Corrective and Preventive Actions (CAPAs).
- Report compliance-assessment metrics and updates to senior clinical, regulatory, and quality-management personnel.
- Promote the company’s quality programs to its customers and employees.
- Develop and implement employee communication and training programs in connection with quality objectives, strategies and processes.
- An advanced scientific degree
- RAPS / RAC desirable
- 15+ years experience leading Regulatory Affairs within the pharmaceutical industry with 7 years of specific leadership and management experience.
- Some oversight of and/or responsibility for Quality teams and activities across a range of GxP development functions.
- Experience leading the Regulatory Affairs and Quality functions, specifically the designing, writing, and submission of regulatory filings and correspondence within a similarly complex specialty/branded commercial pharmaceutical organization.
- Experience leading the submission process for both new entities and line extensions of existing products.
Skills and Attributes:
- Strong leadership competencies and strategic business perspectives required, to ensure that sound drug development, regulatory and compliance practices are fully integrated in all clinical studies, clinical development and post-marketing activities.
- Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly within the FDA and EMA.
- In-depth understanding of the drug development and life cycle management process
- Expertise in Quality and Compliance as well as experience in managing and preparing for regulatory inspections.
- Ideally, a history of active involvement with joint ventures, highly collaborative partnerships, and in/out-licensing of business opportunities.
- The ability to assimilate and interpret trends in the US healthcare policy environment that directly affect business decisions in the pharmaceutical/biotech industry.
- Proven interpersonal and influencing skills. This includes a demonstrated ability to use an open and supportive communication style and to work cross functionally with multiple corporate sites, teams and personalities.
- Excellent oral and written communications skills.
- Commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.
- An entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, attitude and approach.
- The ability to think strategically as well as execute project details.
- Ability and strong desire to work in a dynamic “start-up” environment and be able travel from time to time domestically and/or internationally.