Senior Regulatory Affairs Associate - 1 Year contract
- Contract Type
- The Regulatory Professional under the direction of a Regional Regulatory Lead 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.
- Train and supervise junior staff.
- Strong communication skills - oral and written
- Ability to multi-task in a fast paced environment
- Organizational skills
- Understanding of drug development process
- knowledge and understanding of CMC requirements, especially country specific documents for international filings
- Familiarity with Document Management Systems.
Office based in West London
1 year contract (rolling)
Competitive hourly pay rate
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Sam Chapple on +44 (0)203 868 8607 or e-mail on firstname.lastname@example.org
If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!