Regulatory Affairs Conformance Manager
Hengoed
MAIN PURPOSE:
The Regulatory Affairs Conformance Manager is responsible for planning and managing all
regulatory conformance activity associated with the manufacture of products for Norgine MAs
as well as where Norgine manufactures product behalf of a third party at the Hengoed
manufacturing site.
DUTIES & RESPONSIBILITIES:
 To monitor, plan and organise resources required to deliver on business objectives
 To monitor and feed forward changes in the regulatory landscape under his/her
responsibility
 To provide regulatory advice to Site Quality, External Networks and M&S teams in
relation to possible change requests to improve manufacturing processes, or noncompliance incidents during manufacture. 
 Review of Regulatory dossiers received against Site processes, to support product
licence renewals for European and international markets
 Coordinate the provision of data for US Annual Reports for all products supplied to
USA, on behalf of Sites
 Provision of Registration CofAs for products, Actives and Excipients for New Product
submissions and licence renewals and variation applications to relevant Regulatory
groups.
 Provision of batch data, documentation, GMP declarations, TSE statements and
various data to support regulatory submissions and renewals.
 Provision of stability reports
 Ensure Site Manufacturing and IMP licences are maintained and current.
 Creation of and provision of updates to Site Master Files
 Creation and updates to Site Product Quality Specifications
 Creation of Pharmacopoeial / regulatory driven updates to all Site Raw material
specifications.
 Perform regulatory checks and approval for all Site Laboratory methods
 Provide regulatory approval for all Manufacturing Batch Documents (Batch
Manufacturing Instructions) and for reviews / approval of all updates, in changes are
considered to have potential regulatory implications.
 Work with relevant groups to collate data for Regulatory variations for submission for
filing with Regulatory authorities.
 Monitoring of and provision of individual market regulatory approval information of ongoing Regulatory Changes to Site, including active changes.
 Confirmation of regulatory approval for all New and existing packs prior to supply to
market, and approval for supply of any finished packs, bulk product or intermediate to
Multi-Market Warehouses for onward supply to regional markets.
 Regulatory approval for all site notifications raised in Change Control that require
quality and Regulatory approval.
 To liaise with relevant internal departments and external contacts to ensure
regulatory requirements for change controls are met and to proactively communicate
with stakeholders to expedite delivery of documents
 To participate, provide support to or lead regulatory agency meetings and internal
project sub-team meetings
 To provide advice on applicable regulatory guidelines, project-specific regulatory
issues and matters related to the regional regulatory environment
Norgine Limited
Norgine House, Widewater Place, Moorhall Road,
Harefield, Uxbridge UB9 6NS,UK
Tel: +44 (0)1895 826600 Fax: +44 (0)1895 825865
www.norgine.com
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To communicate the impact of regulatory project plans for those products/projects
under his/her responsibility across the R&D, Business Development, and
Manufacturing and Supply Chain functions
To provide high quality regulatory advice and support to other areas of the Company
To be the primary regulatory resource to Hengoed
To be responsible for the information held within the change control tracking systems
To be responsible for the paper and electronic filing following Records Retention
procedures
To participate in regulatory advocacy and policy activities by interaction with industry
trade associations, lobbying groups and external consultants as necessary
To cover for other Regulatory Affairs Conformance Manager(s) during periods of
absence
INDIVIDUAL REQUIREMENTS:
 Good degree in a relevant life science subject or equivalent, PhD desirable
 Broad regulatory/ quality or manufacturing experience, part of which should have
been gained operating at a senior level, and good knowledge of worldwide regulatory
requirements (including GMP, GLP and GCP)
 A full strategic understanding of the drug development and life-cycle management
principles and processes
 Demonstrates subject matter expertise in Conformance
 Experience in interpretation of ICH and other guidelines pertinent to manufacturing
and conformance activities.
 Demonstrates an ability to analyse and summarise data to a high level
 Good awareness of external regulatory environment
 Focuses on Commercial needs
 Focuses on customer needs, follows up on commitments and requests
 Excellent interpersonal skills
 Excellent verbal and written communication skills
 Leadership skills
 Works cooperatively within a team and leads team as appropriate
 Works effectively without supervision
 Exercises considerable autonomy in decision making and objective setting
 Ability to communicate clearly in English
APPLICATIONS:
Application forms are available by clicking on the Norgine Intranet. All Applications should be
addressed to the Human Resources Department, Norgine Ltd, Tir-y-berth, Hengoed, CF82
8SJ.
Closing date is 3.30pm on Friday 23rd January 2015.