Proclinical is currently recruiting for a Regulatory Affairs - Summer Intern with a biopharmaceutical company located in Santa Monica, CA. In this role, you will learn about the role of a Regulatory Affairs professional in Regulatory Affairs, Chemistry, Manufacturing and Controls (RA-CMC). You will be provided the strategy and knowledge needed to ensure that chemistry, manufacturing and control (CMC) practices are carried out in accordance with the requirements of regulatory bodies, such as the FDA (US Food and Drug Administration) and EMA (European Medicines Agency).
Job Responsibilities:
- The RA-CMC internship will provide the opportunity for interested individuals to develop an understanding of regulations and guidance as they relate to development and global lifecycle management of the Module 3 (CMC) portion of dossiers for cell therapy clinical or commercial products.
- The intern will also learn about the role and responsibilities of key functions that work closely with RA-CMC (Quality, Manufacturing, Process Development, and Supply Chain).
- The intern will receive mentorship from senior RA-CMC managers and have an opportunity to support the development of one or more CMC supplements for products
- Provide support for all regulatory aspects of CMC and assures optimal functioning of internal and external interfaces between RA-CMC and stakeholders for activities across all product development projects. Additionally, RA-CMC closely interacts with multiple functions to create high quality regulatory submissions that support product development strategy.
Skills and Qualification:
- Must be enrolled in the Fall Semester at an accredited university/college after the completion of the internship (certification programs do not qualify) or graduated within 1 year of the start of the internship
- Graduate or undergraduate degree concentration(s) in biologic science, regulatory science, pharmaceutical sciences, bioengineering or similar related degree programs
- Must be available to work full time (40 hours/week) for a minimum consecutive 3-month internship with flexible start in June or July
- Must be able to finance own relocation/housing, if not local
- Proficient in Microsoft Office and similar systems (e.g., MS Word, MS PowerPoint, Adobe)
- Flexible, able to work in a fast-paced, rapidly-changing environment
- Proactive and solution-oriented
- Familiarity with regulatory requirements associated with control and manufacturing of biologics is a plus
- Understanding of scientific principles
To Apply:
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 contact Amanda Rivera at 267-435-8555
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.
Proclinical Staffing is an equal opportunity employer.
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