Our client is a biopharmaceutical company. They have asked us to assist them in their search for a Vice President, Regulatory Affairs .
Major tasks and responsibilities will include:
Supervises team members and consultants to the Regulatory Affairs department. Provides management and guidance across the function. Develops and implements standard operating procedures and common work practices within the team.
Creates and drives the regulatory strategy and early development programs.
Formulates and oversees implementation of regulatory strategy, regulatory interactions, and submissions, both domestically and globally.
Authors, reviews, and critiques documents that will be included in regulatory applications.
Manages coordination, preparation, and timely submission of regulatory documents.
Fosters strong relationships and advocacy with FDA and international regulatory authorities. Develops and maintains relationships with external vendors.
Provides guidance to business development regarding critical evaluation of potential opportunities in support of strategic partnering and licensing activities.
Ensures coordination and collaboration across internal functions and stakeholders. Provides clear and valid regulatory guidance and direction to other departments and project teams.
Maintains expert knowledge of FDA/EMA regulations and ICH guidelines.
Hosts FDA/third party regulatory audits and ensures follow up on findings/observations issued.
We seek candidates with the following qualifications:
Requires 10+ years of experience with increasing responsibility in drug development and regulatory affairs in the biotechnology or pharmaceutical industry.
Requires a minimum of 3 years of leadership experience in a regulatory affairs management role, including the leadership and professional development of the regulatory team.
Bachelor s degree in a scientific discipline required. Regulatory certification (RAC) a plus.
An advanced degree in the biological sciences (MD, PhD, or PharmD) is highly preferred.
Must have demonstrated knowledge in regulatory aspects of clinical development and be proficient in the delivery and conduct of all Regulatory Affairs activities.
Knowledge and management of the regulatory aspects of drug manufacturing, quality assurance, and GCP and GMP compliance highly preferred.
Must have expert knowledge of the regulations and practices of FDA, EMA, and other major health care regulatory authorities; and experience negotiating with and presenting to regulatory agencies.
Experience with NDAs and MAAs and gaining global regulatory approvals preferred.
If interested, please email your resume as a Word attachment to us, reference 3701.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.
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.