Description
Are you a Regulatory Affairs Consultant with experience in Biosimilars? If so our global, leading pharmaceutical client is seeking you! Role to be based in Berkshire, Kent or Surrey.
ROLE SUMMARY
To work with internal groups and relevant project teams to support on-market biosimilars.
To coordinate input to global post-approval strategies for on-market biosimilars. Ensures that global regulatory strategies are in line with the strategic biosimilar business goals.
ROLE RESPONSIBILITIES
Interacts with global regulatory authorities (EMA and other EU/worldwide health authorities as necessary) to manage the lifecycle of on-market biosimilars. This involves:
Marketing Authorisation Maintenance
* Create global regulatory strategies relating to changes to marketing authorisations to support specified business needs. Strategies should achieve the business objectives, have a high probability of being accepted by the regulatory agencies, minimise resource demands and aim to deliver approvals at a time acceptable to the commercial need.
* Coordinate the preparation of initial applications to regulatory agencies and responses to agency questions according to required timelines
* Ensures submission progress concern is communicated to manager
* Coordinate the submission of regulatory applications with Submission colleagues.
Periodic Safety Reports
* Coordinate regulatory actions relating to the preparation/review of Periodic Safety Reports
Launch or Cessation of Marketing Notifications
* Coordinate regulatory actions required upon launch or cessation of marketing
* Accountable for ensuring or contributing to Global Regulatory Strategies and implementation plans (including core labels, risk registers)
* Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, and minimize resource demands while maximizing overall project delivery time.
* Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated
QUALIFICATIONS
* Strong technical background in drug development science
* At least 5 years' experience in EU regulatory affairs ideally with specific biologics development experience and preferably spanning the entire lifecycle.
* Biosimilars experience
* Experience working directly with EMA and/or other health authorities.
Job Title: Regulatory Consultant
Reference No: 237694
Location: Berkshire. Alternatively Kent or Surrey
Job Type: 6 month contract
Salary: £60-80/hr Ltd Company Basis
