Vice President, Regulatory Affairs and Quality Assurance

Vice President, Regulatory Affairs & Quality Assurance

Remote - United States

Seeking a Vice President, Regulatory Affairs & Quality Assurance leader to join a small group with a small yet established global and clinical-stage infectious disease biotech based in the Greater Boston area. This new hire will be responsible for leading all facets of the company's regulatory and clinical quality assurance functions. This is a high-priority position for the business as the company needs strategic FDA input pretty urgently. This new hire will report to the CMO and from their perspective, this VP must be experienced in developing innovative strategies and extremely technically skilled. Seeking a VP that knows the regulations through and through, and when to file/what and how to file is critical for the business.

This new incumbent will work closely with all leaders in the business, including Board Members and stakeholders. You'll be very involved with leading all regulatory activities and strategy developments. Seeking a polished leader to lead interactions with clients and global health authorities (FDA, EMA, ROW), and will be expected to provide sound guidance, leadership, and expertise to the project teams and outside vendors, and external contacts. Ensuring that all strategies are in place and executed to support global regulatory submissions, representing health agencies, and ensuring the development and execution of the company's global clinical QA and PV plans are in alignment with both business objectives and regulatory requirements.

• Strategic development to the following functions: Regulatory Affairs, Clinical Quality, and Medical Writing.
• Lead and guide the regulatory agency interactions, all communications and meetings included.
• Tracking all timelines on regulatory deliverables as well as providing project updates - this will include highlighting any risks that might impact the ability to achieve corporate goals.
• Manage and collaborate with stakeholders globally - clinical, nonclinical/pharmacology, pharmacokinetics, biostatistics.
• Ensure that all regulatory submission documents are fully compliant with internal document standards.
• You will work with the wider team to ensure that all regulatory practices and strategies are fully executed, and all submissions are evaluated and reviewed thoroughly to ensure the following: completeness, well-organized, scientifically accurate, of high-quality, in regulatory compliance, and presented in a manner that facilitates agency review.
• Lead the planning and authoring of clinical submissions and provide authoritative support and advice to teams both directly and through oversight of internal or vendor staff.

Requirements:

• Bachelor's degree in a Scientific discipline required (advanced degrees are highly preferred)
• 15+ years' of relevant Regulatory Affairs and Quality Assurance within the biopharmaceutical industry.
• 10+ years of prior hands-on leadership and management experience.
• , Infectious Disease, and Vaccines experience is highly preferred (-19 is a big plus)
• Track record of success with global regulatory filings and submissions for Biological products; both US FDA and EMA required.
• Working experience of ICH and other regulatory guidances and IND, NDA, BLA process.

If you meet the above qualifications and are interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com for more information.