Our client is a clinical-stage pharmaceutical company. They have asked us to assist them in their search for a Director, Regulatory Affairs.
Major tasks and responsibilities will include:
Assists in work managing and executing regulatory submissions.
Is responsible for NDA & MMA billed submissions.
Ensures regulatory compliance with pre- and post-approval filing and reporting requirements.
Develops strategies and drafts/reviews response strategies and submissions to regulators.
Provides regulatory leadership and guidance to project teams, leadership for the development of global regulatory submission documents, and develops/mentors junior Regulatory staff members.
Develops briefing packages, fast track applications, and orphan drug applications for meetings with FDA and other global health authorities
Actively contributes to the development and implementation of regulatory strategy for assigned projects and programs.
Contributes to the development and implementation of clinical, pre-clinical, and CMC regulatory strategy for projects in all stages of development.
Integrates global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents.
Provides regulatory expertise and supports nonclinical, CMC, and clinical areas for investigational products.
Ensures clinical, nonclinical, and CMC programs are designed and implemented to meet regulatory requirements.
Defines regulatory expectations for project teams.
Manages or delegates the management of the completion of documents and other assigned tasks within established timelines and with high quality.
Performs as the back-up to VP RA at regulatory meetings and liaisons with FDA and other regulatory authorities.
Identifies and assesses regulatory risks for assigned projects or programs.
Prepares and delivers effective presentations for external and internal audiences.
Contacts regulatory agencies relevant to assigned projects or programs, as appropriate.
Participates and contributes in Health Authority meetings.
We seek candidates with the following qualifications:
Masters degree in life/health/technical sciences required.
Must have a minimum of 10 years of regulatory experience.
Requires a minimum of 7 years of regulatory experience within the drug development and approval process in IND/CTAs/Marketing Applications.
Requires knowledge of global regulatory requirements and recent successful NDA experience.
Must demonstrate strong organizational skills and the ability to prioritize personal/direct reports workload.
Requires experience interfacing with relevant regulatory authorities.
Must have experience in the interpretation of regulations, guidelines, policy statements, etc., and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Requires solid knowledge and understanding of applicable regulations.
If interested, please email your resume as a Word attachment to us, reference 3716. 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 Scanlons 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.