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

• Lead the Regulatory Sub-team and as needed, Regulatory Strategic Submission Teams.
• Provide global regulatory leadership regarding biosimilar development and management of submission related documents, and regulatory data for Biosimilars.
• Lead preparation, rehearsal, and manage meetings with Health Authorities.
• As the Regulatory representative in the Biosimilar Development Team and/or other Strategic Teams, develop, supervise, and manage the submission strategy of Biosimilar dossier that best serves the biosimilars business needs, whilst ensuring the work is done in compliance with Fresenius Kabi regulatory procedures and systems. Ensure the regulatory strategy is endorsed by the Development Team or other Decision Committee, as appropriate.
• In alignment with the Development team, establish necessary regulatory story line for regulatory interactions (briefing book consultations and submission dossier).
• In close collaboration with Regulatory Operations, contribute to and support strategies to implement technologies supporting all current and future authorities' requirements and ensure consistency of standards in systems and processes across relevant Biosimilar functions.
• Provide global guidance and support to Market units in their interactions with local health authorities (life cycle management) including mapping of regulatory constraints.
• Contribute to the assessment related to wave 2 submission prioritization.
• Contribute to the Launch Readiness Plans by providing detailed understanding of the regulatory process and by providing guidance on the best regulatory approach (e.g., Labelling, packaging, mockups and artworks).
• Manage entire regulatory submission process including planning, coordination, preparation, application, electronic submission and post-approval monitoring.
• Carry out any other tasks as required by the regulatory function to achieve its mission and objectives (e.g., authoring, review and approval of documents, update of databases such as RIMS, LOQ, HA Interactions, MLR review, coordinate linguistic reviews, support Risk Management Plan (RMM, REMS), support IP as needed).
• Manage change control evaluations for the biosimilar products.
• May serve as back-up for head of RALs biosimilar.
• Drive third-party collaborators for Regulatory tasks, including set up of the interaction
• Mentor Junior RALs.

Job Requirements:

• Bachelor's Degree in life science or related disciplines
• 10+ years of experience in international regulatory.
• Experience managing international or regional regulatory submissions, normally a full
  global submission (new product application), preferably US BLA or EU MAA
• Familiarity with regulatory agency interactions including management of the associated
  documentation and rehearsals
• Advance knowledge in preparation and coordination of regulatory strategy plans.
• Experience in biological product development.
• Experience in CTA requirements.
• Understanding of Regulatory Affairs contribution to Pharma business.
• Fluent command of spoken and written English; additional language skills welcome.

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.