Overview
Reference Number: JO-2210-504306
Regulatory Coordinator Level
Rate: Negotiable
Job Type: Permanent
Location: Warszawa
Role: Regulatory Submissions Co-Ordinator
Location: Poland
Salary: Competitive + benefits
employment: full time, permanent
Job Reference: JO-2210-504306
CPL are collaborating with a midsize, clinical contract research organization. They provide services for Phase I-IV of drug and medical device development services including regulatory services and central laboratory services. Our client is seeking an experienced regulatory affairs professional who has at least 4 years’ worth of experience in clinical research, preferably within a CRO, and knowledge and experience of Clinical Trial Applications within Europe.
Duties will include:
- Prepare, review, and file clinical trial applications to country agencies;
- Provide insightful input on regulatory submissions documents and timelines;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise on changing country regulations and compliance requirements; and
- Track submissions and ensure timely filing of documents.
Knowledge & Skills
- Right to work in the UK
- At least 4 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
- Knowledge and experience of Clinical Trial Applications within Europe;
- Strong oral and written communication skills; and
- Team-oriented approach and strong leadership skills.
If you would like to apply for this position, please contact George via george.eyre@cpl.com. 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*