Your new company

An exciting, globally established, innovative pharmaceutical company specialising in Rare Diseases, covering 3 core areas across rare metabolic, neurological and immunological genetic conditions.

Your new role

• Prepare CMC documentation (M3 and M2 summary documents) for eCTD post-approval submission for main markets such as US, Canada, EU, UK and International markets (MENA, APAC).
• Assist in reviewing/assessing change controls, batch records, and other technical documents.
• Co-ordinate requests for original and legalised documentation to support applications for international product licences.
• Monitor and analyse available regulatory information from key regulatory websites (e.g. FDA, EMA, ICH etc.);
• Communicate the implications of the regulatory intelligence finding to senior members of the team and other functions.
• Provide and maintain MA documentation support by managing submission tracking spreadsheets and databases, and ensuring compliance files are kept aligned with the registered details.
• Maintain knowledge of relevant guidance (in particular US-FDA focused
• Manage Cycle’s Cloud based document management system, exploring and implementing new functionality to improve the RA department’s document management.
• Actively participate in team meetings.
• Work to agreed deadlines, with an ability to respond readily to changing events and priorities.

What you'll need to succeed

• Experience working on product registrations for US and/or EU market (MAs, NDAs, ANDAs).
• Understanding of regulatory procedures, and knowledge of full lifecycle drug development.
• Good technical knowledge of medicinal products including formulation and/or analytical activities.
• UK right to work. No sponsorships at all.

What you'll get in return

Hybrid working

Competitive Salary (£45k - £55k) based on experience

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Raiyan Jawad now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.