Interim Head of Regulatory Affairs (Consultant)

Recruiter
Hyper Recruitment Solutions Ltd
Location
South East England
Salary
£50 to £100
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Contract
Hours
Full Time
We are currently looking for a Interim Head of Regulatory Affairs to join a leading consumer healthcare (CHC) business based in the South East.

As the Interim Head of Regulatory Affairs you will be responsible for leading the local CHC Regulatory team, ensuring compliance of the existing CHC portfolio, approval of all marketing authorizations, input on the development of new products and shape the regulatory environment.

You will be a full member of the Country CHC Leadership team and CHC Regional Regulatory Leadership team.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Interim Head of Regulatory Affairs - Consumer Care will be varied however the key duties and responsibilities are as follows:

1. Manage the RA function and define local RA priorities in line with business and GRA priorities. This will include responsibility for the local RA budget.

2. Ensure Product Packaging information, Marketing Authorisations and high quality Submissions are all in accordance with current product licenses (GRA, SOPs, MHRA interaction)

3. Provide strong guidance to the Country RX Head, acting as interface between the company and local regulatory authorities (e.g. MHRA UK, HPRA Ireland).

4. Co-ordinate the local health authority approval and implementation of risk management plans and DHPCs and educational material.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Interim Head of Regulatory Affairs- Consumer Care we are looking to identify the following on your profile and past history:

1. Minimum MS; Pharm D, MD, PhD or equivalent preferred.

2. Proven industry experience in European and local UK and Irish consumer healthcare regulations and requirements

3. A working knowledge and practical experience with interactions with MHRA and/or HPRA