Regulatory Affairs Manager


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Job ID :


Company Type :

Staffing Firms

Industry :

Science and Research

Education Level :


Address 1 :

United Kingdom,Hertfordshire,Hertfordshire,

Key Skills :

Regulatory affairs, manager, biosimilars, biologics

Salary :

£50000.00 - £60000.00 per annum

Date Posted :

13 Jul, 2016

Company Name :


Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



My client a Global leader in Plasma products is looking to expand their Regulatory team, they are recruiting a Regulatory Affairs Project Manager.

Key Responsibilities:
* To prepare regulatory filing strategies for new Marketing Authorisations in designated territories as well as strategies for the maintenance of existing drug licences.
* To plan for and manage the timely availability of the documentation necessary for applications to relevant authorities and manage the regulatory submission process to approval, through product launch and beyond.
* To write and or review scientific documents and country specific documents needed for submission for new product applications as well as during product life cycle.
* To engage with regulatory bodies as required obtaining new drug licenses as well as maintaining existing licenses in order to achieve regulatory compliance.
* Actively maintain information tools, documentation and procedures to ensure regulatory compliance of products released to market.
* Contribute to the improvement of processes and procedures within the Regulatory Affairs Department and coach other members of the Regulatory team.
* Develop product licensing strategies for designated new products and new markets.
* Manage the regulatory aspects and licensing of Orphan Drugs within the designated countries.
* Obtain Marketing Authorisations in the designated countries or geographical area for designated products and manage the documentation generation process, submission, assessment, approval and product launch regulatory steps.
* Maintain existing licences (commitments, variations, renewals) in designated territory.
* Communicate directly with the relevant departments on the generation of any regulatory documents.
* Communicate directly with the MHRA (country of origin) and other health authorities seeking advice, guidance or clarification of legal issues or submission processes. Active participation in meetings with Health Authorities with or without superior.
* Generate or supervise the generation of regulatory dossiers in eCTD format. This includes writing and reviewing regulatory documentation both scientific data and regional specific data.
* Support commercial operations with preparations for tenders, mock-ups, samples, launches, promotional material, third party business, and distributor/agent contacts.
* Actively maintain RA data bases, documentation and procedures to ensure regulatory compliance of products released to market.

Skills/Experience Required:

* Orphan drugs. Classification and licencing
* Biologicals
* Plasma derived products (added bonus)

Experience with Paediatric data requirements for licensing.
Full knowledge of ICH and all aspects of an ICH CTD including regulatory intelligence. Knowledge or experience of generating eCTD documentation packages.
Thorough experience with EU requirements and procedures (CEN, DCP, MRP, National) for all stages from drug development to final approval and product launch.
* pre-submission meetings with Health Authorities
* Mod 1-5 Dossier requirements
* Post Marketing Commitments
* Change control, change classification & variation management
* launch preparation & promotional material
Experience of managing Biologics Licence Applications to the US FDA from strategy development to final approval and product launch. Knowledge of current USA, FDA legislation and guidance for licensing of biological products. Experience of managing FDA post approval changes
Experience in obtaining and maintaining clinical trial authorisations in the US, EU and Intercontinental region
Experience of dealing directly with Health Authority assessors.
* Suggesting, planning, coordinate/write a proper brief, attend, decision minutes

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or call 01753 589 673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

Company Name:



9 Devonshire Square,


Staffing Firms


United Kingdom





100 - 499


Pharmaceutical Recruitment



Phone No. :

+44 (0) 203 096 47 0

For more information,visit

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