• studying scientific and legal documents• gathering, evaluating, organising, managing and collating information in a variety of formats• ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA)• maintaining familiarity with company product ranges• planning, undertaking and overseeing product trials and regulatory inspections• keeping up to date with changes in regulatory legislation and guidelines• analysing complicated information, including trial data

Reviewing Doc From Adl, R&D, Quality & Prod.• Life Cycle Management Through Amendments / Annual Reports.• Managing Databases And Up-Keeping Of Recording Systems• Preparation And Reviewing Of Regulatory Dmf.• Response To Customer Dmf Queries• Regulatory Response Preparation.• Ensuring Regulatory Compliance In Line With Submission Made. knowledge of USDMF/CEP- Review data for compilation.- Exposure of preparation of USDMF/CEP dossier.- knowledge of regulatory.

• Compiling Product registration dossiers as per ACTD/ CTD/ Country guidelines• Coordination with manufacturing sites concerned departments to source documents• Relevant sample arrangement , countrywise pack designing and checking the text matter on artworks• All activities pertaining to product registration• query replies and registration renewal• Will have to visit the sites as required

• Compiling Product registration dossiers as per ACTD/ CTD/ Country guidelines• Coordination with manufacturing sites concerned departments to source documents• Relevant sample arrangement , countrywise pack designing and checking the text matter on artworks• All activities pertaining to product registration• query replies and registration renewal• Will have to visit the sites as required

Regulatory Affairs Manager required for a 12 month contract role with a leading multinational client based in Cambridge.This role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.Responsibilities:-Advising the GRT on regional considerations in developing strategy-Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders-May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. IMT, IBT, NAMT)-Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment-Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management-Under general supervision participates in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy - includes contingency regulatory planning/risk assessment-Review and approve promotional and non-promotional materials for use in the region-Manage the product lifecycle for individual countries per national agency requirements-Work through the regional leads to manage distributor markets-Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the client's portfolio in compliance with global filing plans and local regulatory requirements.-Under general supervision, implements product-related regulatory strategies, Regulatory ---Affairs processes and activity planning in accordance with national legislation and regulatory requirements.-Provides content guidance for regional regulatory documents and meetings in accordance with GRT strategy

Responsibilities may include the following and other duties may be assigned.*Directs or performs coordination and preparation of document packages for regulatory submissions.*Teams with business unit Regulatory Affairs Specialists and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.*Leads or compiles all materials required in submissions, license renewal, and annual registrations.*Recommends changes for labeling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.*Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.*May direct interaction with regulatory agencies on defined matters.*Support regulatory compliance activities, including manufacturing site registration & GMP, audits as needed.*Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS)

Regulatory Affairs Associate required for a 12-month contract role with a leading multinational client based in Uxbridge or Cambridge.Responsibilities:The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents mostly related to clinical trials in the EU.Over time the scope could expand to also support other regulatory activities like post-approval variations, annual reports, pre-MAA filing or regulatory authority meeting preparations.In collaboration with Regional Regulatory Lead create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications.Ensure compliance via timely submissions to regulatory agencies.Coordinate the collection of functional documents in support of regulatory applications.Coordinate QC of regulatory documentation (e.g. briefing packages).Prepare regulatory packages and cross-reference letters to support investigator-initiated studies.Complete regulatory forms to support agency communications (e.g. EudraCT).Support process improvement initiatives, standards development, and metrics.Assist in template development and maintenance.Actively support regulatory compliance.