Job Summary
Responsibilities
Fresenius Kabi USA, LLC seeks Senior Regulatory Specialist to perform the following duties:
- Represent Regulatory Affairs (“RA”) on project teams and provide regulatory guidance.
- Review technical documents for cGMP and regulatory compliance. Train and coach others in regulatory requirements.
- Prepare and file high-quality submissions to regulatory authorities, including abbreviated new drug applications (“A/NDA’s”), Supplements, Amendments, Annual Reports and drug mater file (“DMF”) updates.
- Communicate the importance of quality assurance and develop quality standards for RA.
- Provide regulatory decisions with regard to acceptability of submission documents and decisions.
- Develop and brainstorm regulatory strategies and options for resolving complex and difficult issues that could result in project termination if not addressed.
- File all applications in accordance with predetermined timelines.
- Represent the company before regulatory agencies and industry groups.
- Use persuasive communication to influence regulatory agencies.
- Train new regulatory scientists on RA and internal systems.
- Mentor regulatory scientists regarding regulations, and provide comments and perspective on proposed regulations.
Requirements:
Must have a Bachelor’s degree in a scientific discipline and 48 months of experience in Regulatory Affairs Specialist or related occupation in pharmaceutical regulatory affairs or related role supporting regulatory submissions & FDA deficiency responses. Must also possess the following (quantitative experience requirements not applicable to this section): demonstrated experience preparing and filing complete A/NDAs, supplements, amendments and annual reports to the FDA. Demonstrated experience working with CFR and FD/ICH guidelines and cGMPs as pertaining to pharmaceuticals.
Salary $103,241.25 to $133,442.00 per year
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, 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, citizenship, immigration status, disabilities, or protected veteran status.
