Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.

The Sr. Specialist for Regulatory Affair s is responsible for regulatory activities including submission, operational and compliance for US-licensed products and additional project/s assigned.

Responsibilities include:

• As the US Product Owner (USPO), responsible for the maintenance of the US dossiers and the execution of lifecycle and regulatory compliance activities of the assigned licensed products in line with business targets and regulatory commitments.

• Responsible for US change control assessment for assigned products.

• Manage regulatory affairs activities including preparation of Annual Report, Change Control assessment.

• Support Global Product Owners (GPOs) to prepare technical sections of US dossiers of post-approval supplements (annual reports, LDRs, PSURs, promotional material and supplements).

• Plan and coordinate the preparation of the answers to Information Requests received from FDA for the assigned products.

• Thoroughly reviews the CMC dossier created by the GPOs to ensure it meets US requirements

• Archive submissions via planning and tracking tools.

• Maintain US licensed dossier baseline.

• Maintain regulatory database including submission, authority correspondence to meet regulatory compliance requirements.

• Other duties as required, and the role will collaborate with tasks across the existing US Regulatory Affairs team

Education/Experience:

• BS/BA/MS degree in science. Minimum of 5 years of pharmaceutical industry experience, of which minimum of 3 years in regulatory affairs.

• Experience in managing US regulatory activities.

• Familiar with FDA regulation and guidelines for post-approval change management.

• Familiar with ICH guidelines.

• Experience in authoring Annual Report and supplements/variations.

• Strong interpersonal skills and project management skills.

• Pay attention to details and can work independently with limited supervision.

• Proficient in use of computer software such as Microsoft Word, Excel, Powerpoint

Kedrion Biopharma offers a number of benefits to qualifying employees, including:

- Medical, vision and dental insurance

- Life and AD&D insurance

- Paid holidays

- PTO accrual

- and much more!

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.