Regulatory Submissions Specialist

Highly Competitive Salary
  1. Permanent
  2. Consultant / Specialist, Publishing & Submissions, RA Intelligence
  3. United States
Cambridge, USA
Posting date: 29 Mar 2021

Proclinical is currently recruiting for a REMOTE Regulatory Submissions Specialist with a pharmaceutical company.

Job Responsibilities:

  • Manage the routine and non-routine submission activity for company portfolio.
  • In collaboration with the Regulatory Lead, design and execute high quality global submission plans, ensuring we deliver compliant submissions to global health authorities within required timeframes.
  • Provides technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submissions, and will act as the primary point of contact for project and/or submission teams when significant planning effort and oversight is required.
  • Be significantly involved in publishing activities and will also contribute to archiving activities of the Group.

Skills and Requirements:

  • A minimum of a Bachelor's degree in a scientific or technical discipline is required; equivalent experience may be accepted
  • A minimum of 4 years pharmaceutical or other related industry experience with 1-3 years of regulatory submission management experience
  • Prior publishing and archiving experience is highly desirable and preferred
  • Submission Management
  • Very knowledgeable in CTD/eCTD structure and requirements and a good understanding of submission requirements for global submission types (e.g. IND, BLA, MAA, NDS, CTA, PSUR etc.).
  • Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines.

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.

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.