Senior Regulatory Consultant

Key People


Job ID :

13417


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--Maidenhead,Maidenhead,


Key Skills :

Regulatory affairs, biologics, biotech, biopharma, contract, associate director, emerging markets, E


Salary :

Up to £0.00 per annum


Date Posted :

02 Nov, 2018



Company Name :

Key People


Location1 :

Maidenhead




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Within this role you will act as Associate Director, Regulatory Affairs and support the Emerging Markets Organisation. The successful candidate will be responsible for leading regulatory strategy in the Emerging Markets region; Africa, Middle-East, Russia CIS and Turkey (EMEA-EM).

The job responsibilities include:
*Working with EMEA Regulatory Liaisons within the EMEA TAs to develop efficient regulatory submission strategy that lead to prompt submissions and optimal product approvals in the EMEA-EM region.
*Develop a high degree of knowledge and familiarity of regulatory initiatives in Emerging Markets by actively participating in Regulatory Policy & Intelligence discussions on EMEA-EM. Assess and communicate impact of the above on submissions strategy in EMEA-EM to the EMEA RL and other relevant stakeholders (where applicable).
*Liaise with CMC groups on CMC dossier content and filing strategy.
*Align with the EMAX initiative to ensure priority filing in selected countries
*By working closely aligned with RSI, meet company objectives and ensure MAA Dossiers are aligned with EMEA Regulatory Strategy, meet local requirements and are dispatched in a timely way.
*Monitor registration status & submission strategy for defined products in the region. By working closely aligned with the ERMC and LOCs, compliantly maintain the regulatory filing and approval database and licence files with correct and accurate licence details (product and manufacturing sites registrations, renewals, CCDS updates, source EU PI versions
*Ensure co-ordination of safety alert/safety issue to Emerging Markets and support EMEA RL with integration into and execution of regional strategies
*Compile licenses renewal plans and track marketing authorisation renewal progress in each country and offer appropriate regulatory support to EMEA RLs.

Experience Required:

*University degree in Life Sciences (medical, pharmacy, biology, veterinary etc.), or equivalent by experience
*Significant relevant experience in Regulatory Affairs of which preferably including time working with Emerging Markets.
*Appropriate understanding of and proven affinity with the Emerging Markets in the region
*Preferably EU and Emerging Markets MAA filling and life-cycle management procedures knowledge and experience.
*Excellent oral & written communication skills in English
*Experience of working in a matrix organization.
*Be able to work with people from different cultural, economic and political background
*Willingness and ability to travel to the region.

For further information about this role, or other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email 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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