Regulatory Operations Submissions Manager

Highly Competitive Salary
  1. Contract
  2. Project Manager, Publishing & Submissions, CMC
  3. United States
Cambridge, USA
Posting date: 05 Feb 2020
RA.SB.27811

Proclinical is currently recruiting for a Regulatory Operations Submissions Manager with a biotechnology company located in Cambridge, MA. Successful candidate must possess a Bachelor's degree in relative field or equivalent with 2 or more years' regulatory operations or affairs experience required.

Job Responsibilities:

  • Manage IND, NDA and MAA submissions (all types, i.e. Clinical, CMC, Nonclinical, etc.) per business priorities and liaise with eCTD vendor to deliver final submission components to be submitted to relevant global health authorities.
  • Quality control checks on electronic common technical (eCTD) components, final submissions, document formatting, hyperlinks and bookmarks and ensure submissions adhere to local health authority guidelines.
  • Maintain and update regulatory information management (RIM) system including submission records, documents, archival of electronic and hard copy submissions and correspondence.
  • Ensure clinical studies, nonclinical studies, drug product / substance manufacturers are logged appropriately in regulatory information system.
  • Participate in user acceptance testing (UAT) and regularly scheduled regulatory information management (RIM) system upgrades.

Skills and Requirements:

  • 2-5+ Years of direct Regulatory Operations or Affairs experience
  • Bachelors' degree in a relevant field or equivalent experience (10+ years in a regulatory affairs function) Regulatory Affairs Master's Degree is a plus
  • Advanced computer skills in Adobe Acrobat and Office 365 Programs, including SharePoint and strong organization skills and a thorough attention to details.
  • Positive attitude, excellent project and information management skills, overall communication which includes written, verbal and interpersonal (non-verbal communication) and intent listening.
  • Strong analytical and problem-solving skills.
  • Works independently, cross-functionally as well as in a team environment.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-SB4
#RegulatoryAffairs

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