Our client is a biopharmaceutical company. They have asked us to assist them in their search for an Associate Director / Director, Regulatory Affairs .
Major tasks and responsibilities will include :
Represents the regulatory function on multi-disciplinary teams.
Develops and implements regulatory strategy.
Provides regulatory leadership in support of development programs.
Monitors, analyzes, and disseminates intelligence on regulatory matters.
Identifies and assesses regulatory risks.
Maintains compliance with applicable regulatory requirements.
Serves as primary liaison with regulatory authorities for day-to-day interactions.
Prepares meeting requests and briefing documents.
Coordinates and prepares teams for meetings.
Ensures timely preparation, review and submission of documents to regulatory authorities to support the conduct of clinical trials and approval of marketing applications.
Coordinates and prepares responses to requests from regulatory authorities.
Manages the regulatory aspects of products and projects including achievement of timelines and deliverables.
We seek candidates with the following qualifications :
Must have an advanced degree (PhD or PharmD) in a scientific discipline.
Minimum of 7 years of experience in Regulatory Affairs within the pharmaceutical industry required.
Requires experience in the preparation and submission of regulatory documents.
Must have knowledge and understanding of global guidelines and regulations.
Requires experience attending meetings with health authorities.
Must have experience leading a team in preparation for interactions with health authorities.
Must have experience with investigational drugs, including late stage development, and marketed products.
Experience managing people and project teams required.
Must be able to work in a cross-functional team environment.
If interested, please email your resume as a Word attachment to us, reference 3748.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.