Regulatory Affairs Specialst EMEA

City of London
£60000 - £70000 per annum + Excellent package
27 Feb 2013
27 Mar 2013
Natalie Hopkins
Contract Type
Full Time

Role 1: Regulatory Affairs Project Manager role / Regulatory Manager

Location: Central London
Salary: £40-45k circa + 32.5 days holiday + bank holidays, career development, extensive training, extremely social, subsidised gym membership, excellent pension, healthcare, childcare vouchers,

This position is ideal for a candidate who is looking for a step up from a Senior Officer / Principle up to a Manager role. This is largely project management but may well lead to some line reports.

Job purpose
The role has three core responsibilities:
- To lead (or support) inspections and investigations, and make associated licensing decisions including making recommendations to senior colleagues where significant regulatory action is required;
- Those regulated, including those who are subject to licensing and inspection.
Other partners, such as the European Commission, Department of Health, Ministry of Justice, Home Office, Care Quality Commission, Health Research Authority, Human Fertilisation and Embryology Authority, Medicines and Healthcare Products Regulatory Agency, and any other relevant agencies.
- to lead (or contribute to) projects and; to lead (or contribute to) the development and implementation of regulatory policies.
- deal with key stakeholders and groups, who require advice and guidance on statutory and regulatory requirements and have sector-specific interests in regulated activities; for example, professional Colleges and associations.

Key tasks and responsibilities
1. To lead (or support) inspections and investigations and make associated licensing decisions.
- To lead and support inspections and investigations in all sectors across the UK, ensuring that all relevant standard operating procedures (SOPs) and guidance are followed.
- To make evidence-based, proportionate and defensible risk based licensing decisions and recommendations
- To assess and monitor compliance with licence conditions, Codes of Practice, licensing standards, and other guidance.
To provide advice and guidance to a broad range of individuals and groups.
* To manage professional relationships with key stakeholders.
* To matrix manage, project manage and line manage staff as required
* To be a proactive member of the regulation team
* To support the Heads of Regulation and the Director of Regulation as required

Role 2: Regulatory Global Project Manager - Global Pharma
Location: Berkshire
Salary: Competitive

Job Responsibilities:
-Provide strategic input into the development of assigned projects handling complex issues, seeking guidance where appropriate.
-Ensure input from sub-team members and issue international regulatory plans as appropriate.
-Attendance at project teams (Brand teams, Product Workstreams, CMC Workstreams etc.) and sub-team meetings, representing EPD RA as appropriate.
-Prepare regulatory filings for submission to international regulatory agencies.
-Manage strategy for response to regulatory agency queries, ensuring scientific dossier content and consistency of scientific content and Company position across geographic areas.
-Coordinate assigned affiliate(s) workload planning & prioritisation and performance
-Monitor actual vs. planned activities and timelines.
-Identify issues impacting project progression and work with manager to recommend improvements to correct or accelerate project progression
-Prepare and present written and oral reports and other presentations to team members and other internal audiences. Adjusts presentation style and content to suit the audience.
-Manage the preparation and review of technical strategic regulatory documentation for agency submission.
-Responsible for ensuring accuracy and quality of documentation.

Education Requirements: Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject


If you want to find out more information contact Natalie Hopkins on 02077587311 or email n.hopkins(a)

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