Regulatory Affairs Consultant 23960-1

Regulatory Affairs Consultant 23960-1
  • Competitive
    HOUR
  • Contract
  • Tadworth, Surrey, England, UK Tadworth Surrey UK KT20 7NS
Job Ref: J2163275
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 11 January 2022
Our client a Global Pharmaceutical Company have opened a new vacancy and are looking to recruit a Regulatory Affairs Consultant.

Our client a Global Pharmaceutical Company have opened a new vacancy and are looking to recruit a Regulatory Affairs Consultant for a 12 month contract based in Surrey.The Role:To allow the company to legally study, manufacture, market and supply medicines. To obtain, manage and maintain product Marketing Authorisations and Clinical Trial Authorisations (where applicable) in line with business goals and legal requirements. Under the guidance and supervision of line management, to conduct associated regulatory activities for the specified markets, and to contribute to the implementation and leading of projects and building of expertise within the Regulatory DepartmentResponsibilities:In line with defined product responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.Provide regulatory input to commercial strategic and operating planning process.Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary. Ensure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities.Build personal expertise through management of specified products within one or more therapy areas.Work with GRA regional strategists to provide country input into Global and European Regulatory Strategies as required.Use expert knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional colleagues and direct or indirect interactions with external customers.Partner with above-country operational hubs to prepare and collate information needed for contribution to departmental and ad hoc reports.Manage and Submit Marketing Authorisation Applications:National/MRP/Decentralised MAA: Partner with above-country operational hubs and GRA strategists to review, co-ordinate and, where required, create necessary technical data to support country submissions e.g. provide national specific module 1 data. Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations. Centralised MAAManage and Submit MA Variation ApplicationsPrepare agreed Module 1 documents in partnership with above-country operational hubs. Review supporting data and ensure that it complies with local regulatory requirements, agree filing strategy with other business functions as appropriate. Prepare agreed Module 2 documents in partnership with above-country operational hubs and GRA strategists and with local medical functions.Lead MRP submission review and planning where country is RMS, in conjunction with GRA strategist.Manage and Submit MA Renewal ApplicationsPrepare agreed Module 1 documents in partnership with above-country operational hubs. Review supporting data and ensure that it complies with local regulatory requirements. Liaise with clinical research project managers to seek to understand clinical research program. In partnership with above country operational hubs, GRA strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including repose to Regulatory Authority queries.Obtain Authority Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)Implement MA Divestments, Cancellations and product DiscontinuationsEducation:Life sciences or chemistry graduate to honours level or equivalentMasters Degree, Post Graduate Diploma or PhD preferredRelevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products)Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferredComputer literacy Excellent written and verbal communication skillsProven strength in analytical thinkingIf you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: corinne.laurence@srgtalent.com or +44161 507 7288.

SRGTalent
10/02/2022 11:08:26
GBP Hour
Contact Consultant:
Corinne Laurence

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