Regulatory Affairs Officer

Regulatory Affairs Officer
  • £45,000 per Annum
  • Permanent
  • Hitchin, Hertfordshire, England, UK Hitchin Hertfordshire UK SG5 1RT
Job Ref: J2163293
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 12 January 2022
SRG are currently looking for a Regulatory Affairs Officer for a leading Pharmaceutical Company who have opened a new vacancy in their Regulatory Team

SRG are currently looking for a Regulatory Affairs Officer for a leading Pharmaceutical Company who have opened a new vacancy within their Regulatory team to be based at their office in Hertfordshire.The Role:To provide regulatory and technical support to the Technical, R&D, Business Development and Quality departments with specific focus on food safety and pharmaceutical regulations in the EU/non-EU and emerging markets.Key Responsibilities:* Responsible for the strategic development and creation of CMC submission documents and lifecycle activities. * Manage the generation, review, approval and submission of product dossiers and CMC regulatory activities for herbal products. This includes Active Substance Master Files and Drug Master Files for products approved by BD Pipeline and Projects committee against the agreed timelines and in CTD format. Respond to queries raised by regulatory authorities engaging QA and Process Development as required. * Work across multiple teams and secure support from the department leads (R&D, Quality and Production, etc) to ensure that company products, which are developed, manufactured and distributed meet the required standards and legislations and regulatory commitments are met. * Act as the regulatory contact to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of a new pharmaceutical substances, to expediate submission, review and approval of global CMC applications. * Responsible for initiating proactive discussions with regulatory authorities to resolve technical regulatory queries relating to product submission * Responsible for market surveillance for changes in regulatory legislation and guidelines in the pharmaceutical, cosmetic, and food and drinks industries, maintaining records where required. * Review of specifications for raw materials, finished products and stability requirements for regulatory compliance. * Responsible for processing and completing customer requests, liaising with the QA team where required. * Keep regulatory files up to date and securely stored (RNL Intellectual Property (IP) confidential information). * Ensure that an NDA is in place with customers before disclosing any RNL Confidential Information or IP. * Maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment. Skills/Experience Required:* Degree in science, or extensive regulatory experience within a GMP regulated environment, preferably pharmaceutical. * Regulatory experience in active substances, herbal substances experience is highly desirable. * Experience in product data collation and submission to competent authorities. * Experience of quality management systems, preferably in a GMP regulated environment. * Expert knowledge of current GMP and food safety requirements. * Desirable: awareness of food safety and/or BRC requirements. If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441615077288

11/02/2022 13:57:31
GBP 0.00 45000.00 Annum
Contact Consultant:
Corinne Laurence

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