Regulatory Affairs Manager job Cambridge Massachusetts
Regulatory Affairs Manager job Cambridge Massachusetts
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Regulatory Affairs Manager Job

Employer Name: SpiderID: 7511216
Location: Cambridge, Massachusetts Date Posted: 4/27/2018
Wage: $100000 - $130000 per year Category: Medical/Health
Job Code: ATB R Affairs Man.

Job Description:

Regulatory Affairs Manager

  • Develop and implement regulatory strategies to facilitate optimum global approval of new medicinal products

  • Planning, execution and assessment of product life cycle management activities and strategies

  • Contributes to the clinical development plans, global regulatory strategic plans, and provides advice on US regulatory clinical trial and marketing authorization requirements to the International Project Teams (IPTs) or Regulatory Sub-team

  • Experience with clinical trial (IND/CTA) and marketing application (BLA/NDA) filing requirements including content requirement, technical writing, and tracking timelines. Ensure the development of high quality submissions

  • Bachelor's degree (or equivalent) in a science-related discipline (e.g., biology, chemistry, microbiology, immunology

  • 8+ years of broad pharmaceutical industry experience, including 4 years of experience of new drug regulated product strategy and submissions

  • Strong working knowledge of U.S. regulatory requirements for biologics

  • Experience with ex-U.S. regulatory submissions and the Drug Development process and working with international project teams

Job Criteria:
Start Date: ASAP
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:
Contact Name: GPAC Company Type:
Company: GPAC

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