Senior Manager, Regulatory Affairs (Strategy and CMC)

Job Summary

The Senior Manager, Regulatory Affairs (Strategy and CMC) delivers regulatory guidance which includes strategic and CMC input in Biosimilar Development and Life Cycle Management to find smart solutions for optimized submission, submission roll out and maintenance. This role will lead specialized and business multiyear critical regional and global projects with key customers.

This role drives autonomously the regulatory strategy during development and life cycle management and coordinates cross functional activities for dossier preparation and submission packages through processes, systems, and tools. Plans and manages submission roll out and maintenance/ life cycle management. This position leads health authority interactions and ensures implementation of feedback in projects. Influences and shapes the regulatory landscape and future regulations. This role has no direct reports.

Salary Range: $140,000 - $170,000 per year
Position is eligible to participate in a 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.

Responsibilities

• Provides global regulatory leadership regarding biosimilar development and management of submission related documents, regulatory data for Biosimilars.
• Leads preparation, rehearsal and manages meeting with Health Authorities.
• As the Regulatory representative in the Biosimilar Development Team, and/or other Strategic Teams, develop, supervises, and manages the submission strategy of Biosimilar dossier that best serve 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 I&D LT 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)
• Act as US Regulatory Lead managing direct interaction with US FDA
• Provides global guidance and support to Market units in their interactions with local health authorities (life cycle management) including mapping of regulatory constraints.
• Actively participate in both internal and external key stakeholder networks
• Perform comprehensive and cross-functional analytics, develop, implement and/or integrate new products processes, guidelines, methods or tools
• Consult executives in business or function related subjects
• Contributes to the assessment related to wave 2 submission prioritization.
• Contributes 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)
• For the assigned products/programs, define and execute an RA-CMC Strategy that best serves the biosimilars business needs and ensure compliance with regulatory systems.
• Manages change Controls evaluation for the assigned product.
• Manages the preparation and finalization of Quality regulatory documents which form the basis of worldwide submissions for clinical trials (IND/IMPDs), initial marketing authorization applications (MAA/BLA M3) and LCM activities like manufacturing site transfers. This includes the preparation and compilation of M3 sections and other CMC related dossier elements (e.g. QOS, M1 CMC elements) in collaboration with internal and external subject matter experts.
• Manages the planning and coordination of CMC related submissions with regulatory functions.
• Tracks approvals and provide regulatory input for changes implementation strategy in close collaboration with Quality, Supply and CMC functions.
• As Business partner to the Biosimilar CMC team and Product Teams, represent the regulatory team in CMC and cross-functional forums.
• Responds to HAs questions in line with the Company CMC strategy. Elaborate responses in close collaboration with CMC teams and site representatives in a timely manner.
• Participates in HAs meetings and present the RA-CMC submissions content to assessors, seeking endorsement of the Company strategy.
• Manages externalization of RA-CMC activities as required.
• Lead the Regulatory Sub-team and Regulatory Strategic Submission Teams, as needed.
• Act as Regional Lead for US
• Manage regulatory submission process through to approval.
• Manage regulatory agency interactions, document preparation, co-ordinate rehearsals and minutes.
• Provide recommendation on submission readiness.
• Keep up to date with the current regulatory environment.
• Act as an interface between other regulatory groups and company functions as appropriate.
• Ensure regulatory CMC requirements are met along the assigned project development work.
• Keep up to date with the latest regulatory CMC requirements through regulatory surveillance. Coordinate timely implementation of any changes or new relevant laws or guidance; provide comments on new laws on behalf of FK-SBS through the appropriate procedure, as applicable.
• Serve as an interface between company functions as appropriate.
• Prepare briefing books and provide support at Regulatory agencies meetings on CMC aspects.
• Ensure that the input in quality development incorporates the outcome of consultations and negotiations with Regulatory Authorities.
• Carry out regulatory review of study / technology transfers protocols and reports used as CMC source documentation for the regulatory sections authoring. Liaise with authors and data generating functions as applicable.
• Ensure regulatory filing systems are maintained and up to date.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
• Other duties as assigned.

Requirements

• Bachelor’s Degree required (Life science or related disciplines)
• 10+ years in Regulatory Affairs including CMC in a biotech environment (preferably mAbs)
• Experience in managing international or regional regulatory submissions, normally a full global submission (new product application), preferably US BLA or EU MAA
• Experience in working in development project teams.
• Experience in leading regulatory agency interactions including management of the associated documentation and rehearsals.
• Experience in preparation and coordination of regulatory strategy plans.
• Experience in biological development.
• Experience in CTA requirements.
• Capability to manage a number and range of projects throughout development.
• Experience in managing international regulatory submissions, BLA/MAA and LCM variations.
• Excellent written and verbal communication skills
• Excellent interpersonal skills
• Understanding of Regulatory Affairs contribution to Pharma business
• Excellent organizational skills, work independently, self-motivated and proactive.
• Attention to details, without losing the overall picture.
• Ability to think strategically.
• Ability to lead regulatory sub team and work in teams.
• Autonomous, goal-oriented and pragmatic
• Strong customer-orientation and strong communication skills

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.

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