Michael Page

Regulatory Affairs Manager

Location
Essex, England / London, England / England, Hertfordshire
Salary
Negotiable
Posted
04 Jun 2021
Closes
02 Jul 2021
Ref
JN -062021-2918382
Contact
Chloe Baverstock
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

The Regulatory Affairs Manager is responsible for providing regulatory support during the development of complex respiratory combination products and the supervision, preparation, and critical review for filings primarily to the US FDA.

Client Details

I have partnered with a global pharmaceutical company to help them recruit a number of people into there Regulatory Affairs Team. A well known global pharmaceutical leader who have a vast portfolio of products spanning across Chemical enties, Generics, Devices, Biosimilars and OTC products. Due to continued success we are looking for a number of regulatory affairs proffesionals to join the team.

Description

The Regulatory Affairs Manager is responsible for providing regulatory support during the development of complex respiratory combination products and the supervision, preparation, and critical review for filings primarily to the US FDA.

  • Manage the preparation, compilation and submission of high quality US controlled correspondence, meeting requests, ANDA filings and responses to FDA.
  • Have scope to potentially manage the preparation, compilation and submission of high quality EU meeting requests, submissions and responses to Competent Authorities.
  • Critically review change controls and work closely with all departments at site to obtain the required documentation for upcoming submissions.
  • Manage quality control over the entire submission lifecycle, including all component tracking, workflow execution and issue resolution.
  • Coach, mentor and provides guidance to regulatory associates as necessary with the potential to line manage in future.

Profile

Regulatory Affairs Manager

  • Doctorate or Bachelor's degree in a scientific discipline.
  • Minimum 5+ years Regulatory Affairs experience.
  • 2-3 years experience in respiratory combination products.
  • Previous Managerial experience preferred.
  • Strong knowledge of current regulations and guidance related to the filing, approval process and maintenance of US ANDAs.
  • Knowledge of current regulations and guidance related to the filing, approval process and maintenance of EU marketing authorisations an advantage.
  • Knowledge of the EU Medical Devices Regulation and Notified Body Opinions an advantage.
  • Demonstrates a good understanding of pharmaceutical drug development for respiratory products.
  • Ability to manage timelines within a project team environment.
  • Ability to work independently, without supervision, and in teams.
  • Ability to establish and maintain good working relationships.
  • Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.

Job Offer

Salary + Great Benefits

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