Job type
PermanentLocation
CambridgeWorking Pattern
Flexible Working,Full-timeSpecialism
Regulatory AffairsIndustry
PharmaceuticalsPay
45,000 - 55,000 (based on experience)
Regulatory Affairs CMC Senior Associate - Cambridge
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.