Job Summary

The Senior Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers. Interact with project teams and regulatory agencies in relation to submissions and other relevant topics. Train new regulatory specialists.

• Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.
• Position requires working onsite 3 days per week in Lake Zurich, IL. Other days may be worked remotely.
• Base salary range: $100,000-115,000.
• Position is eligible to participate in an annual bonus plan with a target of 6% of the base salary.
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

• Represent Regulatory Affairs (“RA”) on project teams and provide regulatory guidance.
• Review technical documents for cGMP and regulatory compliance.
• Prepare and file high-quality submissions to regulatory authorities, including abbreviated new drug applications (A/NDAs, Supplements, Amendments, Annual Reports and drug master 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.
• Train new regulatory scientists on RA and internal systems.
• Mentor regulatory scientists regarding regulations and provide comments and perspective on proposed regulations.

Job Requirements

• Bachelor’s Degree in a scientific discipline
• 4+ years of experience in pharmaceutical Regulatory Affairs or a related role supporting regulatory submissions and FDA deficiency responses.
• Experience in preparing and filing complete A/NDAs, Supplements, Amendments and Annual Reports to FDA.

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

The Senior Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers. Interact with project teams and regulatory agencies in relation to submissions and other relevant topics. Train new regulatory specialists.

• Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.
• Position requires working onsite 3 days per week in Lake Zurich, IL. Other days may be worked remotely.
• Base salary range: $100,000-115,000.
• Position is eligible to participate in an annual bonus plan with a target of 6% of the base salary.
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage

Responsibilities

• Represent Regulatory Affairs (“RA”) on project teams and provide regulatory guidance.
• Review technical documents for cGMP and regulatory compliance.
• Prepare and file high-quality submissions to regulatory authorities, including abbreviated new drug applications (A/NDAs, Supplements, Amendments, Annual Reports and drug master 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.
• Train new regulatory scientists on RA and internal systems.
• Mentor regulatory scientists regarding regulations and provide comments and perspective on proposed regulations