Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in a search for a Director/Senior Director, Regulatory Affairs.  

Major tasks and responsibilities include:

• Supports and leads global regulatory strategy and execution on development programs.
• Manages relationships between the company’s regulatory team and regulatory agencies, CROs, and other third parties.
• Maintains up-to-date working knowledge of US laws, regulations, and guidelines as well as familiarity with the global regulatory environment.
• Leads internal regulatory affairs team and mentors junior staff.
• Coordinates and prepares responses to requests for information from regulatory authorities.
• Collaborates with cross-functional development teams and other departments to achieve project goals.
• Ensures operations are compliant with applicable FDA, ICH, EMA, and industry standards.
• Manages the regulatory aspects of products and projects including achievement of timelines and deliverables.
• Authors, reviews and/or edits documents i.e., Clinical development plans, protocols, informed consents, Investigator’s Brochures, study materials, essential documents, presentations, and reports as necessary.

We seek candidates with the following qualifications:

• A Bachelor’s degree in science-related field of study is required. An advanced degree is preferred.
• Must have at least seven years of regulatory experience in the pharmaceutical/ biotechnology industry or regulatory agency.
• Experience in regulatory interactions with the FDA and EMA regarding development programs is required.
• Requires experience with oncology indications; experience with liver disease or obesity-related indications is also of interest.
• A strong track record of successful submissions and approvals is required.
• Must have excellent working knowledge of drug development process and knowledge of FDA regulatory requirements including EU and global regulatory experience.
• Experience with development stage regulatory compliance and quality requirements is required.
• Effective oral and written communication skills are required.
• Must have the ability to influence and lead without authority, and work within a team-based environment.
• Effective negotiation skills are required.

 
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.