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Job Details

Associate Director/Director, Regulatory Affairs (CMC)

Company: RBW Consulting
Location: Waltham, MA
Reference: RAA-ADRACMC-WMA
Closing Date: 02 Sep 17
Type: Full Time
Salary (£): 100,000+
Benefits:

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Requirements:

Associate Director/Director, Regulatory Affairs (CMC)

Waltham, MA

DUTIES – RESPONSIBILITIES:

The primary responsibilities for this position include:

Assists with timely submission of required documentation to the FDA and other health authorities to support development programs.

Helps to ensure regulatory compliance for and submission of INDs and NDAs.

May participate in interactions with the FDA and other foreign health authorities on behalf of all company development programs and products.

Continually monitor newly published FDA guidelines and international guidance documents that with relevance to new and ongoing development programs. Provide training on applicable requirements for development team as required.

QUALIFICATIONS:

  • Education: Bachelor’s degree
  • Experience: Candidates should have a minimum of 7 years of pharmaceutical industry experience, with at least five years regulatory experience.

 

TECHNICAL SKILLS:

Knowledge and experience in the following areas:

  • Prior experience participating as a team member to successfully complete IND or NDA
  • Working knowledge of drug development process and relevant FDA regulations and requirements
  • Hands-on experience with late stage development programs
  • Knowledge and/or experience with radiopharmaceutical products is highly desirable
  • Knowledge and/or experience with medical devices is highly desirable
  • Strong analytical and problem solving capabilities required
  • Ability to raise risks and propose mitigations/solutions
  • Ability to multi-task and manage multiple deadlines competently
  • Proven ability to work collaboratively with cross-functional development teams to deliver results
  • Supervise regulatory consultants as required

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Associate Director/Director, Regulatory Affairs (CMC)

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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