Pregistry, a CorEvitas Company ("Pregistry"), is a global leader in safety studies during pregnancy. Founded in 2014, Pregistry leverages the expertise of over 70 pregnancy specialists covering a range of clinical, safety, regulatory, marketing, and technology needs to provide information that supports healthy pregnancies and births.
What to expect:
opportunity to work remotely
work with experts in drug and vaccine safety in pregnancy
enjoy working in an international and diverse work atmosphere
This position will provide regulatory strategy and technical expertise to ensure the compliance of Pregistry studies. This includes the development and implementation of regulatory strategies for new studies in alignment with core business objectives. Moreover, this position will help to decrease and/or minimize all associated costs and risks for Pregistry in a preventive, proactive, and dynamic manner.
Scope of Work
Prepare IRB and Ethics Committee (EC) submissions worldwide, respond to IRB/EC queries, and track the delivery of progress reports to IRB/EC, as required
Author content of new regulatory-related or compliance-related policies/programs/projects
Coordinate with foreign language counterparts the translation of documents, as needed
Represent the Regulatory Affairs and Compliance department by developing and executing regulatory and compliance plans
Provide regulatory and compliance support to new and existing projects
Oversee the training activities of all Pregistry staff and track compliance
Ensure files maintain compliance with internal policies.
Acts as a liaison with other departments to support major initiatives.
Support internal and external audits/inspections as required
Responsible for ensuring company compliance with national, state, and local regulations, policies, procedures, and international regulations
Author and train on regulatory-related standard operating procedures and work instructions as required.
3+ years of relevant experience
Must have experience in:
Bachelor’s degree in Business Administration, Legal Management, or related field required
Pregistry develops and conducts pregnancy studies on behalf of pharmaceutical companies. We provide a full suite of services which include next generation pregnancy exposure registries, analyses of claims databases, and surveys to satisfy global regulatory requirements.