Reference Number: JO-2003-448267
Senior Regulatory Affairs Associate – CMC
Job Type: Contract
Role: Senior Regulatory Affairs Associate – CMC
Employment: 12 months contract
Our client is one of the worlds leading biotechnology companies. They are a value-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. In this role you will lead compilation of CMC regulatory packages for submission and may be the lead for a program under supervision.
Collect and / or create country specific documents for regulatory filings worldwide.
Compile and maintain CTA/MA documentation (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead.
Ensure compliance via timely submissions to regulatory agencies.
Coordinate collection of functional documents in support of regulatory applications.
As appropriate support execution of regulatory strategy.
Support process improvement initiatives, standards development, and metrics. Assist in template development and maintenance.
Knowledge, Experience & Skills:
Eligibility to work in the EU
Regulatory Affairs experience in the UK
Experience working with the EU market
Excellent English language skills
Must have CMC experience
If you are interested in discussing this role further, then please email your CV to email@example.com or call Amani on 01189 522 797 to arrange a confidential discussion.
If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*.