Senior Regulatory Affairs Associate

Recruiter
Austin Fraser
Location
Hertfordshire
Posted
11 Feb 2018
Closes
21 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Senior Regulatory Affairs Associate

Hertfordshire/Buckinghamshire

Competitive Salary + Benefits Package

The Company:

Currently working for a leading SME pharmaceutical company based in the Hertfordshire/Buckinghamshire area. This company is going through an exciting transition and needs the SRO to be involved with MAA transfers, of a globally recognised product of which after they will be responsible for the lifecycle management activities of all products, alongside the regulatory team within ROW countries.

Responsibilities:

* Planning, coordinating and submitting MA applications, variations, renewal documents, post-marketing commitment submissions and other ad hoc activities in support of maintaining MAs in UK and RoW markets.
* Reviewing and submitting artwork and labeling changes.
* Working with external pharmacovigilance and medical information agents
* Working alongside external regulatory consultants
* Building and maintaining effective relationships with external clients/partners alongside partner's regulatory teams
* Managing/supporting a range of changing project demands
* Gap analysis of regulatory documentation, identification of potential challenges and proposal of solutions
* Developing and maintaining strong working knowledge of regulatory guidelines

Requirements:

* Bachelor's degree equivalent or higher qualification within Pharmaceutical or relevant life science
* Experience in regulatory affairs/post-marketing activities
* In-depth working knowledge of MHRA, EMA regulations

If you feel this is something of interest then please apply to this advert with your most up to date C.V, alternatively, if you know someone who could be interested in this type of role and we end up placing that individual, we offer a discretionary 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 in the Pharma/Biotech/CRO/Consultancy

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