At ProClinical, we are seeking a talented individual to fill the role of Regulatory CMC, based in Piscataway, NJ.
- Prepare, author, review, coordinate and manage CMC regulatory submissions, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance.
- Contribute to defining the global regulatory strategy, identifying the critical issues and sharing lessons learned.
- Prepare briefing books for Health Authority meetings.
- Identify the required documentation to support global submissions and coordinate the delivery of approved technical source documents in accordance with project timelines.
- Translate the required source documentation into global submission documentation, identifying any content, quality and/or timeliness issues.
- Facilitate consistency within the CMC regulatory documentation by sharing experience and/or contributing to template maintenance.
- Establish and maintain sound working relationships with partners and customers.
- Keep current on regulatory guidelines and requirements in all global regions as well as for new technical trends.
Skills And Qualifications
- Advanced degree in life sciences and 3-6 years' experience in a relevant field. 2+ years of experience in CMC regulatory affairs.
- Knowledge of the drug development process, especially in biologics and/or cell therapy desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
- Strong written, verbal, and interpersonal communication skills.
- Mandarin proficiency preferred.
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 Tudor Carr at (+1) 617-545-5919 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.
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