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Manager - Global Regulatory Affairs-CMC Biologics

Westborough, MA;Bridgewater, NJ

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Responsibilities

 Manager - Global Regulatory Affairs-CMC Biologics

This position will lead the Chemistry Manufacturing and Controls (CMC) Regulatory strategy for Development and Licensed biological products.

This position will direct and provide product strategy and direction to commercial and clinical teams. 

Incumbent will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality.

Experience working in a matrix environment and excellent people skills are required.

Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.  

Major Activities/Key Responsibilities

  • Accountable for file-ability and approvability of CMC clinical (CTA/IND) and commercial filings through involvement at all steps of dossier authoring, review, approval:
    • New applications for biological drugs/devices
    • Post-Marketing Commitments (PMCs) , Follow-up Measures (FUM) and Other Regulatory Commitments
    • License Maintenance: post authorization Changes, recurrent filings:  annual reports (US, Canadian YBPR, license and renewals)
    • Responses to Questions
  • Lead contact and interface with Health Authorities and affiliates on all CMC topics

Qualifications:

Basic Qualifications:

M.S. degree –in a scientific discipline –with 6 years regulatory experience, or B.S. with 8 years regulatory experience.

4-6 years Biologics experience required.

Preferred Skills:

•Able to work in a fast paced environment on multiple product lines

•Excellent organizational and communication (written and verbal) skills.

•Demonstrated ability to work successfully on project teams.

•PhD is considered a plus

•Manufacturing, QA/QC experience

•Proficient in MS Word, Excel, PowerPoint

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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