Regulatory Affairs Project Manager

Watton Hall Limited
South East England
£45K - £50K + Annual bonus
17 Oct 2016
16 Nov 2016
Contract Type
Regulatory Affairs Project Manager


This is a senior position in which a low level of supervision is anticipated. The role demands that the person is able to lead projects, both departmental and those interacting with other departments/ divisions. Accountable for the presentation and accuracy of all documentation prepared and, where appropriate, submitted to the regulatory authorities. Provide regulatory advice and support to the UK affiliates.

Key responsibilities

Gain marketing authorisations for new pharmaceutical products in the UK where appropriate.
Maintain marketing authorisations as required.
Gain regulatory authority approval for new clinical trials and amendments to such trials undertaken.
Liaise with European Regulatory Affairs and Corporate groups on regulatory issues.
Liaise with external regulatory authorities as required.
Draft of packaging texts, SmPCs, PILs and Prescribing Information.
Review of material in accordance with The Prescription Medicines Code of Practice Authority (PMCPA)/ABPI Code.
Liaise and attend meetings with other company functions to provide regulatory advice for new/existing products.
Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements.
Lead/manage regulatory or affiliate projects and interact with other departments as necessary
Mentor regulatory staff as required
Act as deputy to the Regulatory Affairs Manager and indirectly to Director, Regulatory Affairs & QA as required.


Life Sciences Degree or equivalent experience.
Varied regulatory experience including clinical trials and promotional material review
The ability to thrive in a changing environment and to re-prioritise workload to meet business needs
Effective project management experience
Excellent communication skills, both verbal and written
Experience in people management would be desirable
Builds strong relationships with peers and cross functionally and with partners outside of team to enable higher performance
Learns fast, grasps the "essence" and can change course quickly where indicated
Motivates and can influence others, including those over whom they have no direct authority
Professional, accountable, high energy and collaborative team player
Strong communication and interpersonal skills
Ability to work in a fast-paced, high pressure and changing environment in an autonomous manner