Senior Associate Regulatory Affairs - United Kingdom
- Our company is one of the world’s largest independent biotechnology companies, with a global turnover in excess of $18 billion and over 18,000 employees globally.
- For more than 30 years,our company has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient.
- Our company has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
The Regulatory Professional under the direction of a Regional Regulatory Lead will lead, or provide assistance with, the creation and submission of regulatory documents, and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
- Support regional regulatory filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations)
- Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
- Create and maintain product regulatory history documents through IMR/RISE and appropriately archive all regulatory documents and agency communications
- Ensure compliance via timely submissions to regulatory agencies
- Collaborate with CROs / partners to support site initiation
- Coordinate collection of functional documents in support of regulatory applications
- Coordinate QC of regulatory documentation (e.g. briefing packages)
- Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
- Prepare regulatory packages and cross-reference letters to support investigator initiated studies
- Approve drug shipment for our company and Investigator Initiated Studies
- Complete regulatory forms to support agency communications (e.g. EudraCT)
- Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from - and communicate relevant issues to - GRT
- Develop Regulatory Position with teams
- Actively support regulatory compliance
- Support the development and execution of GRT goals
- Graduate in related discipline
- Broad EU clinical trial application experience is essential
- Understanding of drug development process, e.g. clinical trial phases
- Strong communication skills - oral and written
- Organizational and time management skills
Experience in oncology therapeutic area (preferred)