Job Title: Regulatory Affairs - CMC Officer, to support activities and projects of the Regulatory & R&D department
Main duties and responsibilities:- Preparation and submission of Marketing Authorisation, renewal and variation applications (via National, Mutual Recognition & Decentralized Procedure) which involves reviewing supporting data and ensuring compliance with regulatory requirements in eCTD and non-eCTD format (Modules 1-5) according to applicable Health Authority (HA) and dossier formats.
- Provide clinical and nonclinical document support and preparation of Modules 2.4 and 2.5 (Clinical Overview and Nonclinical Overview) and Modules 2.6 and 2.7 (Clinical Overview and Nonclinical Summaries) of the CTD including literature review and references, clinical pharmacology, efficacy, and safety
- Clinical justification documents for EU, US and other emerging Regulatory markets
- Contact gap analysis for dossiers in clinical part
- Biowaiver support and providing justification document services
- Implementation of variations, SmPCs, PIL and packaging amendments through regular liaison and correspondence with European Affiliates, QPs, Artwork and Pharmacovigilance personnel
- Conduct extensive literature research and studying of scientific and legal documents
- Assistance on the Tech Transfer and MAH Transfer processes
- Preparation and national translations of the Product Information (SmPC, PIL and Labeling) in accordance with current guidelines
- Preparation and Reviewing of Mock-ups (Artworks)
- Medical writing, scientific discussion and protocol preparation
- Liaise with external Regulatory authorities as required.
Requirements - The ideal candidate should have:
- BSc Degree in Pharmacy, Chemistry, Biology or relevant field. Higher degree in one of these fields or Regulatory Affairs is preferred.
- At least 2 years of experience in Regulatory Affairs with a strong CMC background in a pharmaceutical company or a Contract Research Organization (CRO).
- Knowledge of all key regulatory pathways expected (National, MRP/DCP, Centralised, IND/NDA) alongside key regulators (MHRA, EMA, FDA for example)
- Knowledge and experience in the regulatory field of medical devices, supplements and/or cosmetics will be considered an asset
- Hands-on experience in the compilation, review or publishing of technical sections of Marketing Authorisations (i.e. Module 3, 4 or 5 plus overall summaries)
- Proficiency with a wide range of information (CMC, clinical, non-clinical, manufacturing etc)
- Excellent communication in English language (writing & speaking) and good MS Office skills
- Ability to work under pressure, resilience
- Strong problem-solving, troubleshooting skills
- Demonstrated ability to work on multiple projects and meet timelines
- Effective communication and relationship management