Regulatory Affairs Manager

2 months ago
Requisition ID
2017-3031
Job Location(s)
Pittsburgh PA United States
Travel
20-30%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Regulatory Affairs

Overview

Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full-time Regulatory Affairs Manager. The Regulatory Affairs Manager will work closely with the management team to serve as the strategic resource for applying global regulatory requirements to the clinical and manufacturing development of the company’s product lines. This position will serve as the Regulatory Affairs representative and regulatory point of contact for cross-functional clinical teams and will assist in the development of best practices for Regulatory Affairs processes.        

Responsibilities

• Provides regulatory oversight to the company’s Biological License Application initiatives
• Manages the regulatory aspects of projects/products, including major, complex applications submitted to regulatory agencies
• Provides regulatory advice and interpretation of global regulatory requirements applicable to pre-market and commercial programs
• Ensures clinical activities are in compliance with global regulations and resolves complex regulatory issues
• Applies interpretation of regulations with respect to phase-appropriate clinical development
• Ensures regulatory submissions (for IND, IMPD, BLA, NDA and/or PMA) are complete, properly formatted, and comply with applicable regulatory requirements
• Assists in writing, reviewing, and editing clinical trial documentation, including clinical protocol, Investigator Brochure, and annual safety reports
• Interfaces directly with governmental agencies and personnel, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications
• Reviews and critically analyzes clinical trial data and independently interprets and summarizes clinical results
• Provides regulatory input on marketing and patient recruitment materials
• Writes clear, user-friendly, product information leaflets and labels
• Applies scientific and technical knowledge of product to evaluate regulatory impact on product life cycle management

Qualifications

• Masters degree in Life Sciences discipline with 7+ years of direct regulatory affairs experience or a Ph.D. in Life Sciences discipline with 4+ years of direct regulatory affairs experience, in biopharmaceutical industry
• Regulatory Affairs Certification (RAC) preferred
• Familiarity with domestic and international regulatory requirements
• Experience in the preparation of clinical trial documentation for submission filing, including working knowledge of GCP and technical understanding of regulated products, biologics experience is preferred
• Demonstrated scientific and/or medical writing experience
• Able to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining high level of attention to detail

 

Physical Requirements:

• Requires up to 25% travel

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