Director of Regulatory Affairs Job in West Chester, Pennsylvania US
Director of Regulatory Affairs
Apply Now See all jobs at this company Printer-Friendly Version | Save this job | Email this job Director of Regulatory Affairs Apply Now Job Overview Company: Aerotek Job Type: Pharmaceutical Base Pay: N/A Other Pay: Based on Experience Employee Type: Full-Time Manages Others: Not Specified Relocation Covered: Not Specified Industry: Biotechnology Reference ID: 2516204 Required Education: Not Specified Required Experience: Not Specified Required Travel: Not Specified Location: West Chester, PA 19380 ( Map it! ) Loading map ... Job Description Job Classification: Direct Hire A small biotech client of ours in the West Chester area is searching for a full time, direct placement Regulatory Affairs Director ASAP. Responsibilities: - Develops and implements all effective proactive regulatory strategies for product development, labeling or promotional issues. - Insures that all Regulatory Affairs activities and contractors are managed in an appropriate manner to comply with all of the Company's budgetary objectives. Manages/reviews all work of regulatory affairs contractors and maintains official Regulatory Files. - Direct and manage all submissions to regulatory agencies, including FDA, (ex., NDA filings and supplemental applications, INDs, IND Annual Reports, CTDs, Meeting Requests, Briefing documents, and other submissions). - Review and approval of promotional materials and labeling, in cooperation with Medical Affairs, for FDA approved products. - Participate in due-diligence review and evaluate licensing and product line opportunities, from a regulatory perspective. - Reviews and approves all scientific and technical protocols and reports required for regulatory submission to the appropriate authority. - In conjunction with Quality and Compliance, create and manage an RD/Product Development system to ensure the required documentation is prepared and audited for FDA submissions. - Interface either directly with FDA and other regulatory agencies, including scientific reviewers, administrative staff and management, to facilitate the review and approval of regulatory applications. Responsible for negotiating highly complex issues with senior regulatory agency officials pertaining to applications or labeling/promotional submission. Requirements: Must have a Bachelor's Degree, or higher. Must have significant (8-10 years experience) in submissions and Regulatory Affairs. Join Aerotek Scientific 74 LLC, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Job Requirements IND/NDA, DERMATOLOGY, Submissions, Promotional Labeling/Marketing Apply Now