Regulatory Affairs Manager

Austin Fraser
11 Feb 2018
12 Mar 2018
Contract Type
Full Time
Senior Regulatory Affairs Manager


Competitive Salary + Benefits Package

Due to expansion, I'm working with a globally recognised company searching for a Senior Regulatory Affairs Manager, the company is one of the top 20 pharma companies and specialises in 3 unique area's.

They are looking to grow their already high performing Regulatory Team even further by bringing this individual in; you will be responsible for all CMC activities across the business and implementing strategies to bring products through clinical trials.

Duties & Responsibilities:

* Prepare state of the art, compliant CMC documentation to support clinical trial applications, marketing authorisation applications, and product lifecycle maintenance
* Project manage and lead tasks, which may have a high degree of impact to the business.
* Responsibility for the management of LCM activities in compliance with the existing legislation and policies
* Evaluate and assess due diligence activities and Business Development projects for Regulatory CMC and report to Senior Management to tight timelines.
* Provide CMC input on development project strategies and provide support to ongoing development projects.
* Develop and maintain proactive relations with key individuals such as stakeholders, and influencers
* Responsibility for the management of product registration activities
* Decide on the strategy to address any CMC specific questions from Regulatory Agencies, Associate Companies, other Regulatory Affairs personnel as required.

* Experience/Qualifications

* Relevant Life Science Degree
* Minimum 6 years experience previously working in regulatory affairs
* In-depth knowledge of local and European regulatory affairs legislation
* Skilled at developing positive working relationship and influencing others

If you feel this role isn't right for you however you know someone who could be interested and we end up placing that individual, we offer a £200 referral fee

Due to the nature of this role, I have been receiving a large volume of applications, if this is of interest then please get in touch asap

Please note: Candidates must be eligible to work in the U.K and have had to come from a Regulatory Affairs background working with either foods or food supplements

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