Associate Director Regulatory Affairs

Regulatory Affairs Associate Director | Hayes Our client is seeking an experienced Regulatory Affairs Associate Director who will manage and oversee the regulatory activities that underpin the supply of unlicensed and pre-reimbursement medicines into the global market. Company Overview: We are working with a leading service provider within the pharmaceutical and healthcare sector headquartered in Ireland; their three trading divisions work in synergy to support communities with the medicines and support that they need. Global company that is constantly growing Competitive salary and comprehensive benefits package Job Overview: Act as an in-house regulatory expert, advising and supporting the Business Units and project teams Providing guidance regarding current unlicensed regulations and guidance (EU, UK, and ROW) to internal and external stakeholders Creating and maintaining Regulatory Intelligence related to unlicensed product supply as well as understanding and communicating the impact of new, existing and pending regulations, guidelines, and standards Oversight and ownership of regulatory elements of all packaging and labelling activities for the GMP activities associated with unlicensed medicines supply Drafting and maintaining regulatory procedures as required To be successful: Regulatory experience and experience in developing regulatory strategy Ability to work proficiently within Microsoft Office Suite systems (Word, Excel, and PowerPoint) Prior experience of working within the Unlicensed Medicines supply service sector is ideal Prior experience of preparing group or cohort regulatory submissions for unlicensed medicines supply (e.g. cATU in France, CUP in Germany, EAMS in UK) Experience within a client-facing, service role How to apply: If you like the sound of this opportunity and you’re ready to take the next step in your career, we would love to hear from you! Please click the 'Easy Apply' button or contact Danny Dorward on 01225 336 335 for more information. Seniority level

Mid-Senior level Employment type

Full-time Job function

Quality Assurance and Science Industries

Pharmaceutical Manufacturing

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