Senior Regulatory Affairs Officer

Key People


Job ID :

11821


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Hertfordshire,Welwyn Garden City,


Key Skills :

regulatory affairs, principle officer, principle regulatory officer, post marketing, CMC, generics,


Salary :

£40000 - £45000 per annum + bonus + excellent benefits


Date Posted :

12 Jun, 2018



Company Name :

Key People


Location1 :

Welwyn Garden City




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An excellent opportunity has arisen to join a leading Generics company at a Senior Regulatory Affairs Officer level. Within this role you will be responsible for managing EU registration and post approval activities as well as mentor junior staff and gain basic line management responsibilities.

The ideal candidate will be highly motivated and energetic and have a strong background in EU registration and post approval activities. You will have a strong understanding of regulatory affairs, ideally between 3 - 5 years, and have an excellent knowledge of MRP/DCP, National and CP submissions across the European markets. This is an excellent opportunity for a driven individual with excellent communication skills to join a world leading generics company. If you are looking to gain project and line management experience, this role could be for you.

Responsibilities:

- Ensure suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatched on-time according to agreed company procedures and objectives.
- Ensure on-time submissions for all safety related changes for assigned projects.
- Ensure SPPs for all assigned projects are maintained in-line with current SOPs and guidance.
- Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.
Provide mentoring and training to (Associate) Regulatory Officers and/or (Senior) Regulatory Assistants as directed by Line Manager.

For further details about this role, or for a confidential chat about other opportunities within Regulatory Affairs, please contact Tim Barratt on 01727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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