Head of Regulatory Affairs - Fairway Consulting Group : Job Details

Our client is a Non-profit organization. They have asked us to assist them in their search for a Head of Regulatory Affairs. Major tasks and responsibilities include:

• Oversees regulatory strategies and operations interactions for entire portfolio.
• Manages and improves regulatory documentation and archiving.
• Holds responsibility for ensuring appropriate regulatory compliance across activities and programs.
• Works closely and actively with other functional areas to ensure the successful and timely execution of programs.
• Actively participates in overall management and policy decisions as a member of the leadership team.
• Works closely with the CEO to ensure the effective development and engagement of regulatory strategy.
• Serves as the primary spokesperson for the organization on matters of global regulatory policy.
• Serves as the primary contact for international regulatory bodies and global policy organizations, such as the WHO.

We seek candidates with the following qualifications:

• Must have fifteen years of pharmaceutical leadership experience in regulatory strategy and operations with a strong background in vaccine, biologics, and infectious disease therapeutics development.
• Requires experience in clinical regulatory aspects of product development.
• Requires experience in the management of regulatory documentation and compliance, and in the management of a regulatory functional area.
• Must have the ability to demonstrable depth and breadth of regulatory strategy through a combination of experience in pharma and biotech.
• Experience leading regulatory strategy including nonclinical, CMC, and clinical considerations is required.
• Must have previous experience in conducting all regulatory affairs activities including meeting submissions, IND, and clinical trial applications and regulatory filings.
• Requires knowledge of regulatory pathway programs such as orphan drug, breakthrough, accelerated approval and related designation programs in the US and the equivalent in non-US jurisdictions.
• Must know how to resolve conflicting input from different regulatory authorities.
• Must have a successful track record of negotiations with regulatory authorities and successful movement of investigational products through regulatory approvals.
• Experience in working with regulatory authorities in low-income countries is required.
• Must have expertise in regulations of ICH, FDA, and EMA.
• A working knowledge of regulatory regimes in additional countries (such as India, China and other Asian countries) is preferred.
• Must have a thorough knowledge of GLP, GMP, and GCP regulations.
• The proven ability to effectively utilize and manage external regulatory consultants and CROs is required.
• Must be an experienced advisor to senior leadership with a track record of significant contribution to developing strategic planning alternatives.
• Requires experience building capability, both internally within their own organization and externally with a range of partners.
• Requires demonstrated success in leadership roles developing and managing complex and highly dynamic, technical organizations to work collaboratively toward a common vision.
• Proven strength in structured problem solving and strategic business planning with the ability to synthesize disparate information and critically analyze complex situations is required.
• Must have experience in the identification of knowledge gaps and leading the organization and analysis efforts to acquire needed data and address gaps.
• The ability to navigate a wide range of operational and strategic issues, including industry, government, legal, IT, financial, and HR is required.
• Must have knowledge of strategy development and implementation to design performance management systems consisting of goals, targets, and monitoring processes.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email. Fairway Consulting Group is included in Hunt Scanlon's list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms .