The Regulatory Affairs Specialist is responsible for preparing on-time preparation and filing of high-quality regulatory submission files such as CMC, IND, DMF and BLA's as well as support and obtain regulatory approvals, post-approval maintenance of regulatory dossiers, and maintain both quality and regulatory compliance. In addition, this position will interact with project teams and regulatory agencies in relation to submissions, compliance, and other relevant topics.
Job Specific requirements
Experience / Education:
Knowledge / Skills / Abilities:
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability