Reference Number: JO-2108-474488
Regulatory Operations Associate II
Job Type: Contract
Senior Regulatory Operations Associate
Initial 12 month contract with good potential for extension
Remote based working with occasional travel to Cambridge site
Attractive remuneration package
CPL Life Sciences is privileged to work with a leading biopharmaceutical organisation who are actively seeking an experienced Senior Regulatory Operations Associate to join their established team on individuals support EU submissions. The ideal candidate is an individual committed to Regulatory publishing and submissions and enjoys working with a diverse and varied fast paced working environment.
Job Responsibilities includes;
Shall have experience with electronic CTD/eCTD publishing software, as well as knowledge of regulations and guidelines across the EU
Competent in implementing full submission standards where applicable and be able to provide QC review of said standards, such as the hyperlinking and bookmarking of regulatory documents.
The candidate will be responsible for ensuring that all final electronic deliverables meet current regulatory electronic document requirements and guidance.
Candidate will prepare submissions and applications in the Common Technical Document (CTD) in electronic formats with some additional paper requirements as appropriate.
The candidate must also be detail-oriented, thorough, and methodical.
The candidate shall establish and comply with standard operating procedures for publishing regulatory submissions.
Candidate Requirements include;
Eligibility to live and work in the United Kingdom
Minimum of 3 years Regulatory Publishing or Submissions experience
Prior experience covering EU regions is highly desirable
Strong communication skill and good attention to detail
If this position is of interest to yourselves please forward your up to date CV to firstname.lastname@example.org for more information.