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Job Details

Regulatory Affairs Manager

Company: SRG Woolf Group
Location: Rockville, MD
Reference: JO000065869
Closing Date: 09 Mar 18
Type: Contract
Salary ($): Competitive
Benefits:

Job Summary:

One of our global pharmaceutical clients is currently seeking a Regulatory Project Manager! Although we work with offices nationwide, this position is based in the Rockville, MD area. This is a fantastic work opportunity with competitive pay! This is an initial 8 month contract position.

Requirements:

PURPOSE OF POSITION: To provide guidance to functional area authors/reviewers with regards to submissions and dossier requirements. To understand, interpret, and advise on regulations, guidelines, procedures, and policies relating to the development, manufacture, and successful global registration of biopharmaceutical products. To directly manage completion of multiple dossier components to meet project timelines, among other responsibilities.

EDUCATION/SKILLS: Bachelor's degree in life sciences or related scientific discipline. Minimum of 5 years experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related activities and functions. Experience in authoring CMC content for regulatory submissions is required, preferably with a minimum 2 years in regulatory affairs or related function.

SRG Woolf is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

Apply for this job: Regulatory Affairs Manager

Contact Information:

Address:  Head Office
2841 Plaza Place
Suite 210
Raleigh
NC 27612
USA
Tel:  1-877-966-5347
Website:  Visit Our Web Site

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