Our client is a clinical-stage biopharmaceutical company focused on developing medicines for life threating diseases. They have asked us to assist them in their search for a Director, Regulatory Affairs Strategy.

Major tasks and responsibilities include:

• Interacts with key regulatory agency personnel to ensure the review and approval of development proposals, the timely resolution of issues, and the approval of applications.
• Leads planning, organization, and conduct of formal meetings/teleconferences with regulatory agencies.
• Develops strategy for regulatory submissions to health authorities worldwide in support of our client’s pharmaceutical/medical device combination products in Phases I-III.
• Oversees organization and compilation of regulatory submissions and other correspondence.
• Ensures compliance with internal SOPs, and local, regional, national, and international regulatory laws, standards, and regulations.
• Utilizes regulatory expertise and knowledge of regulations and guidance documents to strategically interpret, plan, and communicate requirements to the product development team.
• Reviews and provides interpretive analyses of regulatory precedence, guidance documents, regulations, and emerging regulatory initiatives to the product development team and management team for assessment of the potential impact on development programs.
• Ensure project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner.
• Maintains up-to-date knowledge of the relevant precedence, regulations, and health authority guidance.
• This role may have direct management of consultants.

 
We seek candidates with the following qualifications:

• A bachelor’s degree in life science or a related discipline is required; an advanced degree is preferred.
• Requires a minimum of 8 years of prior pharmaceutical/biotechnology industry experience, including at least 6 years in regulatory affairs.
• Experience in vaccine and/or oncology development is strongly preferred.
• Must have expertise in US regulations with direct experience in successfully interacting with the FDA with global regulatory expertise preferred.
• Proven experience preparing INDs, CTAs, BLAs, NDAs, MAAs, and health authority meeting briefing documents; regulatory project leadership is preferred.
• The ability to effectively collaborate with cross-functional departments to drive meetings and meet each program’s critical regulatory milestones.
• Must have excellent communication skills (verbal and written), regulatory writing skills, interpersonal and organizational skills, and attention to detail. Willingness to share knowledge and lessons learned.
• Requires technical proficiency, effective problem solving, and critical thinking skills.
• Capability to prioritize multiple projects and submissions, consistently meet tight timelines and work effectively both independently and within a team environment.
• Must have the capacity to travel ~10%, both international and domestic.

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 40 Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms.