Please review the following job description, if you are interested and meet the requirements, then please refer to the job number when applying for this position.
The referral of your friends and colleagues are appreciated.
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Manager Regulatory Affairs - Massachusetts
Job # 5573
Job Type: Full Time, regular position
Local candidates
Requirements:
Bachelor's Degree (pharmaceutical/ life science field of study preferred)
3+ years' experience in regulatory affairs within the Pharma/ Biotech industry.
Candidate must show a demonstrated knowledge of FDA/CBER regulations.
Vaccine experience is very desirable as is familiarity with international regulations.
The hired individual will work on problems where the scope and analysis of situation or data requires evaluation of identifiable regulatory strategy and law. Candidate must be able to review regulatory documents, identify inconsistencies or incomplete/incorrec t information, and provide corrections.
Job Responsibilities:
Interface with Regulatory Agencies, answering regulatory questions.
Provide regulatory guidance to functional areas.
Ensure rapid and effective development and review of regulatory documents to be submitted to the FDA and international regulatory agencies.
Coordinate with preclinical, clinical, medical affairs, manufacturing and quality control groups to ensure regulatory submissions are reviewed and approved to meet project target dates.
Develop, implement, and adjust, as needed, regulatory strategies during the development phases of the assigned project(s).
Coordinate comments to draft guidelines and provide Regulatory Department's interpretation of guidelines to functional areas, as needed.
Manage and co-manage regulatory projects, working independently with minimum supervision.
Will hire and supervise an associate when the scope of the project requires.
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Thank you,
Abbas Masnoon
Professional Placement Consulting Group, Inc.
A Nationwide Professional and Executive Search Firm
Tel: 508-234-6674
resume@@ppcginc.com
