Our client is the world’s leading chemical company and the leader in sustainable chemical solutions. This division manufactures and conducts research on enzymes used for human and animal nutrition as well as for detergents and cleaners. They seek a Senior Regulatory Specialist at this Southern California R&D location.
This role provides regulatory support to the Director, Biotech Regulatory Center of Expertise to ensure compliance with applicable US and international regulations in which the company does business; preparing product submission documentation, and providing guidance to project teams as it relates to application of regulatory requirements.
Prepare and maintain regulatory submissions, including U.S. Food & Drug Administration (FDA) submissions, Environmental Protection Agency (EPA) submissions, and other international submissions as required
Conduct regulatory assessments, reviewing, and approving manufacturing changes as appropriate * Interfacing with Research & Development (R&D) teams to collect relevant information, test reports, and technical discussions for regulatory submissions
Monitor changes in international and domestic regulatory compliance issues
Maintain regular communication with team members to facilitate international registrations and approvals
Assist in the development of new Regulatory Department procedures
Model basic process safety rules and regulations on site; understanding safety requirements and their importance (prevention, preparedness, emergency plans, reaction to alarms).
Bachelor’s degree in Biology, Food Science or related field, e.g. Molecular Biology, Microbiology. MS degree, preferred.
Minimum of 5 years’ of experience in Regulatory Affairs, preferably with prior experience in the biotech industry
Demonstrated experience comprehending, interpreting and conveying scientific information, both orally and in writing, to develop a high quality regulatory submission
Experience applying FDA food regulations, food cGMP’s, EPA TSCA regulations, and / or NIH Guidelines for research involving rDNA molecules to biotech products
Demonstrated experience effectively interacting with regulatory agencies including FDA
Demonstrated experience developing, implementing and managing programs in support of regulatory compliance
Demonstrated experience working cross functionally, maintaining project focus to meet timelines
For more information, please contact Moira McGrath, OPUS International, Inc. (954) 428-3888 e-mail firstname.lastname@example.org