Senior Regulatory Specialist

4 days ago

Apply Now

Receive Emails with Similar Jobs

Avantor

WebsiteLinkedInAll Job Openings

Life Science • Advanced Materials • Pharmaceutical Chemicals • Biopharmaceutical Chemicals • BioMaterials

10,000+

Description

• Execute product compliance strategies, policies, and processes • Participate in product design reviews • Provide guidance and training to prevent compliance issues • Collaborate with multi-site engineering and manufacturing • Support ongoing Sterility Validation program • Manage customer questionnaires and surveys related to compliance • Assist in developing and revising Standard Operating Procedures

Requirements

• Bachelor’s degree in Science, Engineering or related work experience • 5+ years experience in Quality and Regulatory roles, including medical devices and/or biopharmaceuticals • Knowledge of cGMPs and USP/ISO Standards • Strong experience with MS Office • Ability to carry out tasks in a timely, accurate manner • Effective communication skills, both written and verbal • Ability to interact with all levels of the organization • Ability to multitask in a fast-paced environment