Job SummaryPrepare and file high-quality submissions to regulatory authorities, including A/NDA's, Supplements, Amendments, Annual Reports and DMF Updates.Responsibilities
- Develop regulatory strategy for difficult issues that could significantly impact project timelines and costs.
- Provide regulatory decisions with regard to acceptability of submission documents and decisions.
- Represent Regulatory Affairs on project teams and provide regulatory guidance and share expert knowledge of complex issues.
- Review technical documents for cGMP and regulatory compliance.
- Represent company with regulatory agencies and industry groups.
- Train new regulatory scientists on Regulatory Affairs and internal systems.
- Bachelor's degree (or higher) in drug regulatory affairs, chemistry, biology, or foreign equivalent or related field (willing to accept foreign education equivalent)plus two years of experience in supporting pharmaceutical regulatory affairs.
- Demonstrated expertise (DE) preparing and filing complete A/NDAs, Supplements, Amendments and Annual Reports to the Food and Drug Administration (FDA)
- DE proofreading preprinted labeling materials, including vial, tray labels, cartons, and package inserts
- DE tracking, renewing and completing new state licensing applications based on requirements per state
- DE preparing regulatory applications utilizing expertise in CFR, FDA/ICH guidelines and cGMPs.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.