Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
Job Description
Join our team of experts, providing support in all regulatory aspects of clinical studies. You will be part of a dedicated team committed to quality and timelines, ensuring the smooth initiation and conduct of projects involving novel pharmaceutical products.
We are currently seeking someone who will take ownership of serious breach administration tasks within the regulatory framework and support clinical study submissions, approvals, and compliance activities specific to the United Kingdom.
You will:
- Support PSIs global serious breach group by documenting, filing and tracking potential cases of serious breaches of GCP, applicable regulations and/or the approved trial protocol
- Track regulatory project documentation flow and progress reporting
- Liaise with project team to procure documents necessary for regulatory and ethics committee submissions, ensuring these meet local requirements.
- Prepare submission dossiers within planned timelines and submit to the authority and ethics committee.
- Review investigational product release-enabling documents.
- Maintain regulatory study lifecycle, manage changes in the study as applicable (by means of submitting notifications/supplemental applications).
- Deliver regulatory training to project teams.
- Assist with feasibility research and business development requests, if requested.
- Manage safety reporting to authorities
Qualifications
- College/University degree or an equivalent combination of education, training and experience.
- Minimum of 1 year of prior industry experience within the CRO or pharmaceutical industry
- Understanding of requirement to adhere to the Clinical Trial Regulations.
- Strong organizational skills with the ability to manage multiple projects simultaneously
- Excellent time management skills and ability to meet tight deadlines
- Ability to interpret and apply complex regulatory guidelines
- Communication, collaboration, and problem-solving skills
Additional Information
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. At PSI, we create an environment where adapting, evolving, and improving processes comes naturally. Our Regulatory team is highly responsive, supportive, and flexible, always working to deliver a standout service experience for both internal and external customers.
