Regulatory Submissions Specialist

2 days left

21 Jul 2017
18 Aug 2017
Contract Type
Full Time

Regulatory Affairs 6 month contract (extension potential)with a global leading pharma client. Experience of European Submission Required

Job Description: Position Purpose
Supporting initial and post approval submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets.
Ensure dossiers are produced, dispatched to assigned markets and are submission ready.
Work in collaboration across the regulatory organization with stakeholders to deliver efficiencies in Regulatory submissions and processes.

Primary Responsibilities
* Manage initial and post approval submissions for assigned markets
* Manage initial and post approval strategy and execution to ensure a submission ready dossier.
* Communicate changes to regulatory requirements
* Ensure submission packages are reviewed against local CMC requirements
* Contribute to local and regional regulatory initiatives
* Assist in ensuring internal regulatory processes and procedures are well documented

Technical Skill Requirements
Knowledge of the European regulatory environment and how this impacts regulatory strategy and implementation.

* Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
* Prior experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or Compliance
* Strong knowledge / background of EU regulatory procedures and requirements

* Experience in regulatory affairs or compliance preferably in human medicines - 5 years of experience as a minimum.
* Demonstrated regulatory experience with a pharmaceutical company
* Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.
* Regulatory experience including knowledge of Europe submission product lifecycle management processes.

Job Title: Regulatory Affairs - Regulatory Submissions
Reference No: 234922
Location: Surrey
Job Type: 6 months contract