Sanofi Group Senior Manager Global Regulatory Affairs CMC Biologics, Westborough, MA in Westborough, Massachusetts

Job Description

This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical biologic products. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. Incumbent will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality.

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

May supervise and coach a team of regulatory professionals and be responsible for their development.

Provide support for other CMC projects as needed. Experience working in a matrix environment and excellent people skills are required.

Major Activities/Key Responsibilities

  • New applications for biologics

  • Plan/Prep/Submit/Review support for product dossiers

  • CTA / IND preparation and maintenance

  • License Maintenance

  • Recurrent filings: annual reports (US, Canadian NDC and YBPR, license and renewals)

  • Site renewals (ex. Japan Accreditation)

  • Post Approval Supplements

  • Regulatory strategy development

  • Preparing / Authoring / Review of Submissions – US, EU and Rest of World (ROW)

  • Technical Review of site supporting documents (CoA, declarations, SMF, MBR, SOPs)

  • Notify Reg Ops for publishing and dispatch to BoH

  • BoH Response to Queries – US, EU and ROW

  • Interaction / liaise with EMA and EU member state BoH on CMC topics

  • Post Approval Supplements

  • Regulatory strategy development

  • Preparing / Authoring / Review of Submissions – US, EU and Rest of World (ROW)

  • Technical Review of site supporting documents (CoA, declarations, SMF, MBR, SOPs)

  • Notify Reg Ops for publishing and dispatch to BoH

  • BoH Response to Queries – US, EU and ROW

  • Change Controls

  • Change control assessments

  • Initiate change in regulatory database and follow-up with local regulatory representatives on the assessments of the change.

  • Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations.

Ideal Background (state preferred education and experience level)

Qualifications

Basic Qualifications:

University degree in scientific discipline with 3-5 years regulatory experience.

Knowledge of FDA regulations is essential.

Experience with biological products

Preferred Skills:

  • Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.

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

  • Demonstrated ability to work successfully on project teams.

  • RAC certification preferred.

  • Previous experience working in a fast paced environment on multiple product lines

  • Manufacturing, QA/QC experience

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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life