- Leading a small team, handling the regulatory activity across a large portfolio of medicine and medical device/ combination products
- Working with EU, UK, and RoW regulatory bodies; as the subject matter expert for Medicines; Medical Devices and related ISO activities (including ISO13485 and ISO14971); Controlled Drugs; Nutritional Products; In Vitro Diagnostic Devices; Biocidal Products
- Review and support for submission of new product dossiers and technical files – both own development, in-licensed and out-licensed and all aspects of regulatory lifecycle maintenance for existing products
- Author technical documentation, including EU eCTD dossier sections, technical file documents and product artwork, for alignment with applicable regulations and guidance and assessing suitability for submission where appropriate.
- Regulatory Strategy and Scientific Writing
- Finial signatory on artwork and labelling material
- Minimum of 5 years of Regulatory Affairs experience in a relevant pharma environment
- Educated to degree level in a relevant life science discipline
- Must have line management experience - ideally 3 or more direct reports
- Worked in a broad role, covering R&D projects and CMC knowledge
- Must be commercially astute , with regular interactions with regulators and external stakeholders
- Must have proven experience with EU and UK regulations for medicinal products/ devices
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Regulatory Affairs Manager - Hampshire, United Kingdom - Blackfield Associates
Description
Job Description
Our client, an independent pharmaceutical company who manufacture and specialising in generics, have an opportunity for an experienced EU/ UK Regulatory team leader to join their team in Hampshire.
As Regulatory Affairs manager, you will:
To be considered for the role of Regulatory Affairs Manager, you will:
Due to the nature of the team, this person will be required at the Hampshire office at least 2 times a week. Hybrid working.
