Head, Global Regulatory Affairs

North Carolina
Our client is a clinical stage biopharmaceutical company. They have asked us to assist them in their search for a Head, Global Regulatory Affairs.  

Major tasks and responsibilities will include:
  • Acts as primary regulatory contact and strategist with the FDA, international regulatory agencies and other regulatory bodies.
  • Provides innovative regulatory approaches and oversight in the development of the company’s portfolio from IND or equivalent to filing and approval.
  • Provides regulatory oversight for product development, manufacturing and commercial operations.
  • Provides overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally.
  • Monitors the US and international regulatory environments and provides senior management with assessments of the impact of new and changing regulations on the company’s business.
  • Develops and implements training programs for direct reports and other functional groups to assure awareness of all requirements and maintain compliance with all current regulation.
  • Coordinates the review and approval of product labeling and advertising.
  • Reviews and interprets regulatory rules and ensures that they are communicated through company policies and procedures.
  • Identifies issues early in the submission process that could potentially impact product launch.
  • Determines submission requirements and coordinates plans and timelines with project management.
  • Contributes, reviews and approves clinical strategies and protocols.
  • Negotiates and interacts with regulatory authorities during the development and review process to ensure submission approvals.
  • Contributes and in some instances leads the creation and review of regulatory documents, including premarket approvals applications, clinical study protocols/data and CMC.
  • Reviews marketing materials and claims to ensure compliance with regulatory requirements.
  • Supports technical filings for ROW registrations.
  • Monitors regulatory outcomes of initial product concepts and provides input and advice to the senior management team.
  • Provides regulatory review and advice on business development opportunities including regulatory due diligence.
  • Reviews and advises on international product registration requirements, making recommendations to management regarding regulatory process and strategies.
  • Supports the organization on regulatory matters, complaints, potential recall concerns or any other regulatory related situation.
We seek candidates with the following qualifications:
  • BA/BS degree required, preferably in a health/life sciences or related field.
  • Minimum of 15 years of industry experience with increasing responsibilities in regulatory affairs is required.
  • Prior experience with CMC Regulatory including IND/ strongly preferred.
  • Requires demonstrated experience leading multiple NDA filings.
  • Must have extensive experience interacting and leading meetings with the FDA.
  • Proven experience and knowledge in leading and executing in bio-pharma and/or pharma organizations is required.
  • RAC or similar certification strongly preferred.
  • Requires a strong understanding of regulatory authority guidance, including ICH.
  • Global regulatory experience is required.
  • Rare disease experience is preferred.
  • Respiratory therapeutic experience preferred.
  • Experience presenting to Board Members and Investors preferred.
  • Must be a demonstrated people leader.
  • Prior experience leading a team responsible for life cyclic regulatory requirements post approval strongly preferred.
  • Business travel 10-20% as required.
  • Requires previous experience with regulatory filings and interactions with US and EU authorities.
  • Must be recognized as an expert in regulations, guidelines and precedents related to clinical and pharmaceutical development, labeling and promotion.
  • Requires substantial knowledge and experience with regulatory affairs and regulations.
  • Demonstrated ability to develop and maintain excellent working relationships with regulatory authorities is required.
  • Must have current knowledge of global regulatory changes and impacts to the market.
  • Must have experience appearing before regulatory agencies and health authorities with the ability to interact and present effectively.
  • Must be able to anticipate and respond to questions and to report back to senior management and colleagues.
  • Requires clinical intelligence and understanding sufficient to interact and communicate at a scientific level in discussions.
  • Must be highly familiar on the clinical side with the ability to manage and even advise, as appropriate.
  • Outstanding record of managing and integrating the programs of entire function within the regulatory affairs department is required.
  • Requires compelling interpersonal verbal, written and presentation skills in communication with internal and external customers.
  • Must have demonstrated business management experience and understanding coupled with the ability to enable successfully, simplifying the complex to drive alignment and understanding amongst various parts of the organization.
  • Must have demonstrated experience hiring, leading, and developing regulatory team members and enabling high performing regulatory teams.
  • Ability to prioritize and enable and accelerate multiple programs and projects and strong management skills are required.
  • Proven responsiveness and success in a dynamic environment where change is frequent and rapid understanding and alignment is required.
  • Requires demonstrated aptitude for ‘hands-on’ troubleshooting and problem solving with an exemplary history as a “self-starter”.
  • Strong desire to work as part of many cross-functional teams is required.
  • Requires proven ability to lead organizational change.
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.
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