Vice President, Regualtory Affairs and Quality
SiteOne Therapeutics
Job Title: Vice President, Regulatory Affairs and Quality – R&D Clinical Science
Purpose Of This Role
Working with the Chief Medical Officer, the Vice President, Regulatory Affairs will provide strategic and day-to day leadership for the Company’s Regulatory Affairs department. The Vice President will develop and execute a Regulatory strategy, including appropriate staffing. He/She will work closely with the company’s Clinical Operations, Compliance, Legal, Manufacturing and Medical teams, to meet overall Company objectives.
The Vice President, Regulatory Affairs will take the lead in all Regulatory aspects of drug registration applications, on a global basis and anticipate and ensure effective post-approval Regulatory activities and results. As a member of the Leadership Team, he/she will also contribute to the Company’s overall strategic direction and key tactical management issues. He/She will effectively represent the Company’s interests in regulatory and commercial discussions.
Major Responsibilities
The Vice President, Regulatory Affairs will:
- Develop and lead implementation of the Company’s overall regulatory strategy to ensure timely and successful achievement of key Regulatory milestones during the drug development and approval phases; as well as ensuring effective post-approval Regulatory response and compliance.
- Serve as a credible, influential, respected corporate liaison and spokesperson during all interactions with regulators and regulatory agencies.
- This role must sustain excellent regulatory compliance and strengthen and expand relationships with key regulatory bodies in the U.S., and in other markets as required.
- Leads/oversees the preparation of Regulatory documents and filings in all phases of development and post-approval.
- Hire, manage and develop Regulatory Affairs staff to ensure these teams deliver expected levels of excellence.
Additional responsibilities include:
- Develop Regulatory Affairs strategies that will shorten approval times and improve product labeling.
- Oversee the management of marketed products, ensuring all reporting obligations are met, including PSURs, annual reports to both the FDA and ex U.S. regulatory bodies. Lead the regulatory function in strategizing and executing additional clinical trial programs for sNDAs.
- Oversee the assembly of regulatory packages for IND submissions for new product development.
- Provide current regulatory information on a proactive and/or as needed basis.
- Liaise effectively with domestic and international regulatory agencies.
- Provide leadership on the Company’s regulatory interactions with and presentations to regulatory agencies, customers, and partners.
- Prepare and/or monitor the preparation of high quality, timely regulatory submissions.
- Ensure conformance to commitments to various health agencies (e.g., FDA, EMA, HC).
- Oversight of all ICSRs, PADERS, PSURs, DSURs and other reports to global regulatory authorities.
- Collaborate of the revision of Pharmacovigilance SOPs and generation of new SOPs as necessary.
- Review and approval of Study Protocols, Clinical Study Reports, Statistical Analysis Plans, and ISE/ISS.
- Act as the responsible Company contact during audits of Pharmacovigilance.
Profile (Skills, Experiences and Qualifications Required for The Job)
Education:
Successful candidates will have a bachelor’s degree from an accredited college or university, advanced degree preferred.
Background and Experience:
- A minimum fifteen (15) years’ experience in Regulatory Affairs, including at least eight (8) years’ experience managing staff.
- A results/problem solving orientation supported by strong project and planning management skills.
- The Vice President should have extensive experience with direct agency interaction, including the FDA.
The successful candidate will be:
- Demonstrated ability to lead a Regulatory team, and to identify emerging Regulatory issues and initiate actions.
- Demonstrated knowledge of global (U.S., EU, AND ICH) regulatory requirements and the ability to apply knowledge, both strategically and operationally to develop projects and marketed product regulatory issues.
- Expert working knowledge of regulations and specific experience in the area of new product development, advertising and promotion, Pharmacovigilance, and the ability to support multiple commercial products.
- Demonstrated strong negotiating and problem-solving skills.
- Proven ability to manage multiple projects, set priorities and meet deadlines.
- Demonstrated excellent technical writing skills.
- Excellent verbal and written English communication skills.
- Ability to speak publicly in front of diverse groups, of all sizes including, development and delivery of presentations to Boards of Directors, Agencies and Executive Teams.
Key Selection Factors
The successful candidate should have the following key selection factors:
- This individual must have a minimum of fifteen (15) years’ experience in the pharmaceutical/biotechnology industry.
- He/She must have demonstrated success in leading Regulatory Affairs, team building and contributing strategically at an executive committee level.
- The VP Global Regulatory Affairs should have experience leading all activities for drug registration applications and ensuring positive post approval regulatory activities.
- The successful candidate must have experience gaining regulatory approvals for new drugs. In addition to pre-registration responsibilities, she/he will have competency in post approval regulatory response and compliance.
- This individual must serve as a leader, and the center of expertise, for regulatory strategy and intelligence both internally and externally.
- He/She must be current on strategy and all regulations in all major markets globally and be able to communicate related matters to the executive committee and Board.
- The ideal candidate must be a strategic thinker capable of successfully representing the company with regulators and regulatory agencies both in the US and globally.
- She/he should have experience serving as a credible and respected spokesperson during all interactions with partners, regulatory agencies, and all external parties.
- Successful candidates must have experience as a manager leading and developing others.
- She/he must be comfortable contributing in a team environment. She/he should have a minimum of eight (8) years’ experience supervising regulatory affairs employees.