Regulatory Affairs - Senior Manager

3 days left

GI Group
Hertfordshire, England, Hatfield
20 Apr 2021
20 May 2021
Claire Paas
Regulatory Affairs
Full Time
Contract Type
Experience Level
Senior Management

Regulatory Affairs - Senior Manager
Fixed Term Contract (up to 12 months)
Competitive Salary

Exciting opportunity to work for our International pharmaceutical client, who is looking for an experienced Manager in Oncology who will be responsible for life cycle maintenance for this asset and providing strategic support for the activities. The senior manager will represent the team with regards to these activities at project teams and at senior management updates, as required.

Main duties and responsibilities:

* Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome
* Work may include policy changes or recommendations
* Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
* Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues
* Contact with clients and external vendors and troubleshooting routine client inquiries.
* May represent the organisation as a prime contact for technical matters of significant complexity
* Directs the activity of a work team project within the department.
* Develops and implements regulatory strategy for own functional area and region
* Leads issue resolution of regulatory risks by identifying, escalating and monitoring issues
* Organises resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed time-frames.
* Complies with all applicable laws / regulations of each country in which we do business
* Reports legal, compliance and ethical violations in a timely manner
* Contributes to the planning, execution, and assessment of product life cycle management activities and strategies

Skills & Experience required:

* Experience in regulatory methods and processes.
* Proven knowledge of UK regulations including clinical trial regulations.
* Experience in liaising with regulatory authorities (both in writing and verbally).
* Life cycle management for Centralised products, including Type I and Type 2 license variations, line extensions, negotiating labelling with regulatory authorities.
* Excellent written and verbal communication skills.
* Strong problem solving skills and eye for detail.
* Must be able to operate in a complex environment and adapt well to changes.
* Experience in the Oncology therapeutic area would be preferred.

If you are interested in this role and feel that you have the right skills then please click apply.

For further details, please contact us on 01707 247259

Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.

Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited and Grafton Professional Staffing Limited. We are committed to protecting the privacy of all of our candidates and clients. Following some recent changes to data protection laws we have updated our Privacy Policy. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group UK website.