Our client is a biotechnology company in genome engineering. They have asked us to assist them in their search for a Head of Regulatory Affairs.
Major tasks and responsibilities will include :
Leads internal regulatory affairs on all relevant and current global guidelines.
Navigates effective paths to therapeutic approvals.
Provides guidance on regulatory mechanisms from pre-IND to product development on preclinical, clinical, and CMC elements.
Manages and executes all regulatory activities, including submission and maintenance of US and international regulatory filings.
Implements quality assurance methodologies and oversees product development, including the creation of SOPs.
Serves as primary liaison with regulatory authorities.
Oversees the writing of pre-meeting briefing materials, leads the preparation for and facilitates sponsor interactions at regulatory meetings, and ensures appropriate follow-up.
Works closely with external consultants and CDMOs.
We seek candidates with the following qualifications :
Bachelor’s degree in the life sciences required. Advanced degree (MS, PhD, MD) highly preferred.
Must have a minimum of 5 years of regulatory affairs management experience in the pharmaceutical industry.
Quality assurance experience highly preferred.
Requires solid knowledge of the drug development process, as well as, FDA / EMA / ROW regulatory submission and maintenance requirements.
Must have strong strategic and analytical abilities, diplomacy, negotiation, and excellent oral and written communication skills
Requires solid understanding of cGXP regulations and must be able to provide guidance on regulatory compliance.
Must be detail- and goal-oriented, quality conscientious, and customer focused.
If interested, please email your resume as a Word attachment to us, reference 3803. No calls or faxes, 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.