Pharmaceutical Manufacturer and Developer requires an experienced Regulatory Support Officer, 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.
Duties may include:
- 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 Chemical Manufacturing Control (CMC) regulatory activities for herbal products. This includes Active Substance Master Files (ASMF) and Drug Master Files (DMF) for products approved by BD Pipeline & Projects committee against the agreed timelines (as per the guidelines of each country) and in Common Technical Document (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. Contribute to the Site Quality Council with summaries of changes to the regulatory landscape for the industries and territories in which the company is active.
- 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.
- Accountable for Regulatory and related communications across site both internally and externally.
- Interface with BD, Technical, R&D and QA departments.
Skills and experience:
- 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.
- Able to process complex information and present this simply to the intended audience to ensure understanding.
- Excellent written and verbal communication skills and actively breaks down communication barriers.
- Driven, committed and resilient.
- Proactively seeks professional and personal development opportunities.
- Capable of working with large volumes of data, with a focus on data checking, bulk uploading and electronic submission with great accuracy.
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