Senior Regulatory Affairs Manager

SRG

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Job ID :

2055


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Slough,Slough,


Key Skills :

Regulatory, CMC, Biologics, Manager


Salary :

£60000.0000000 - £70000.0000000 per annum + +Benefits


Date Posted :

11 May, 2016



Company Name :

SRG


Location1 :

Slough




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Responsibilities

* Drive the preparation of CMC sections of regulatory submissions and obtain agreement on the regulatory strategy from all stakeholders.
* Develop the regulatory strategy for new variations, response to questions and change controls. Ensure all CMC dossier data remain relevant, compliant, and current and an accurate reflection of all CMC related aspects of the products, processes and practices.
* Participate in gap analysis activities as needed, prioritising and planning associated regulatory strategies to address any identified gaps.
* Maintain efficient, compliant and robust systems, procedures and processes so that everyone involved in the CMC dossier preparation process is clear as to their role, providing the right data in the right format, as per schedule and in compliance with requirements.
* Monitor the development of existing pharmaceutical regulations and communicate them to all appropriate functions.
* Lead the timely submission-readiness of CMC dossiers for the allocated product portfolio. Coordinate all related CMC Regulatory activities including responses to questions from Regulatory Agencies.
* Monitor and report on CMC Regulatory activities and process performance for the allocated products; identify areas for improvement, implement and monitor subsequent actions.
* Assess CMC Regulatory impact of all changes proposed to the allocated product portfolio, propose and communicate prioritisation of changes to reflect company/department objectives.
* Perform a regulatory review and impact assessment of change controls pertaining to planned changes at manufacturing sites.
* Ensure optimized communication with the vendors and partners involved in the CMC regulatory process.
* Ensure proper execution of the CMC Regulatory process and related activities.
* Ensure the QP are provided with accurate and up-to-date CMC Regulatory information that is needed to ensure proper and fully compliant release for each market.
* Collaborate with the Associate Director, - External Manufacturing to ensure strategy and work plans are aligned.

Experience / Qualifications

* MSc in a life sciences discipline. 7-8 years of pharmaceutical experience with at least 5 years in the preparation and submission of CMC filings (modules 1 as well as Module 3 and 2.3) for European and/or US markets. Including Solid Biological experience
* Proven significant experience in the biological field (Drug Substance essential) Sound technical knowledge of the manufacture of pharmaceuticals and sterile biological drug substances and drug products and the appropriate understanding of all CMC disciplines.
* In-depth knowledge of EU regulatory requirements pertaining to the manufacture of pharmaceutical and sterile biological drug substances and drug products.
* EU strategic experience in post approval variations.
* An in depth knowledge of knowledge of regulations and submissions within other regions such as the US, Switzerland, Israel and Taiwan would be advantageous. Regional HQ experience preferred.
* Strong regulatory writing experience and familiarity with eCTD formats and publishing support functions.
*

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:

SRG


Headquarters:

9 Devonshire Square,


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC2M 4H


Website:

www.srg.co.uk


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

+44 (0) 203 096 47 0


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

View all SRG Jobs



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