Senior Regulatory Consultant

Company Summary

Our client is one of the top global companies bringing innovative ideas, products and services to advance the health and well-being of people all over the world. They are currently seeking a Regulatory Consultant specialising in CNS/IM to work on a contract or freelance basis at their R&D European Regulatory Affairs Department.

Regions: Europe, Turkey, Israel, South Africa, New Zealand and Australia

Job Summary

Regulatory consultants will work for a global regulatory leader either in the CNS or IM therapeutic area or in the mature products area. They will work on the practical aspects of the compounds assigned from clinical trial applications (CTA’s), ASR’s, requests for scientific advice, MAA preparation, variations, renewals, PSURs etc depending on the life cycle of the compounds assigned. They may work on one or several compounds depending upon the work required for any compound at the time.

Duties and Responsibilities

The work has several aspects

1) Communication to the Global Regulatory Teams and the supporting functions for regulatory submissions, such as clinical.

2) Working with the local operating companies within the allocated region and external communication to regulatory authorities in the regions and to the EMEA.

3) Working in a group that covers both developmental compounds not yet licensed and the maintenance and further development of marketed products. You will be responsible for the regulatory activities in the regions and inputting the global regulatory aspects for the compound.

4) Work according to the Regulatory Affairs Professional Template*
* Prepare and submit under supervision the following regulatory submissions in line with relevant legislation by following the relevant department Standard Operating Procedures (SOP’s) and legislation associated with these activities. ( See below)

The activities:
* Abridged Marketing Authorisation Applications and Type II (complex) variations
* MRP Variations: type 1A and 1B, Type II
* Renewals
* Periodic Safety Reports
* Annual Safety Reports
* Clinical Trial Applications (CTA’s)
* Amendments to CTA’s and CTA compliance activities
* Leaflet and label changes as required
* Co-ordinate the preparation and submission of briefing documents for Health Authority meetings/review as appropriate.
* Provide regulatory input into product lifecycle activities by participating in product teams at both a local, EU and Global level as required.
* Maintain the products logs/files relating to regulatory activities e.g. receipt of health authority questions
* Liaise with Regulatory Authorities either directly or via local operating company personnel – discuss administrative or procedural issues relating to submitted or proposed Marketing Authorisation, variations and other regulatory activities as needed.

Qualifications and Experience:

1)Communication skills are key in this role in addition to being able to communicate clearly with people from other countries.

2)All candidates must be able to exhibit a background of being highly organised, adaptable with excellent attention to detail.

3)A broad knowledge of all regulatory processes involved in product development, launching and post approval as well as extensive experience in the required therapeutic areas.