At ProClinical, we are seeking an individual to fill the role of Regulatory Affairs Specialist, based in Irvine, CA. The successful candidate will provide support for the regulatory department to ensure efficient and compliant business processes and environment.
- Assist in SOP development and review.
- Provide regulatory input to product lifecycle planning.
- Assist in development of regional regulatory strategy and make updates when necessary.
- Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context to assess regulatory implications for approval.
- Determine trade issues to anticipate regulatory obstacles.
- Determine and communicate submission and approval requirements.
- Participate in risk-benefit analysis for regulatory compliance.
- Monitor applications under regulatory review.
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
- Assist in preparation and review of regulatory submission to authorities.
- Maintain annual licenses, registrations, listings and patent information.
- Assist compliance with product post marketing approval requirements.
- Assist in the review of advertising and promotional items.
- Assess external communications relative to regulations.
- Review regulatory aspects of contracts.
- Assist with label development and review for compliance before release.
- Provide regulatory input for product recalls and recall communications.
- Contribute to the development and functioning of the crisis/issue management program.
- Ensure product safety issues and product-associated events are reported to regulatory agencies.
- Submit and review change controls to determine the level of change and consequent submission.
Skills And Qualifications
- Experience in several fields of expertise, including medical writing, advertising, labeling, controlled and restricted substances, import/export and country-specific regulatory support.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mary Jacobs at (+1) 2674774800 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.