Senior Manager, Regulatory Affairs (Biosimilars)

Job Summary

The Senior Manager, Regulatory Affairs delivers Regulatory Affairs and compliance guidance and strategic input as a subject matter expert in Biosimilar Development and Life Cycle Management to find smart solutions for optimized submission, submission rollout, and maintenance. Autonomously drive the regulatory strategy. Manage cross functional activities for dossier preparation and submission packages through processes, systems, and tools. Plan and manage submission rollout and Maintenance / Life-cycle management. Manage and lead health authority interactions and ensure implementation of feedback in the projects. Influence and shape the regulatory landscape and future regulations. This role will lead specialized and business multiyear critical regional and global projects with key customers.

• This position may be worked remotely in the U.S., and because of regular engagement with our European and Asian colleagues, the workday starts early.
• This position does not offer visa sponsorship either now or in the future.
• Salary Range : $165,000-175,000
• Position is eligible to participate in an annual bonus plan with a target of 14% 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

Job Requirements :

global submission (new product application), preferably US BLA or EU MAA

documentation and rehearsals

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 , andwellness 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.