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Director Regulatory CMC

Waltham, Massachusetts



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"One of the best things about Sanofi Genzyme is the consistently fun and dynamic work environment that I get to be a part of."

Kristin Ouimet Regional Business Manager

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

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"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders


Job Description:

Reporting to the Head of Global Regulatory Affairs CMC Biologics this position will be responsible for a Product Range Team and lead the Regulatory aspects of Chemistry, Manufacturing and Controls (CMC) for licensed and clinical biological products in development. Working with R&D as well as Industrial Affairs and Technical Development colleagues this position will develop and lead the product strategy and oversee the direction of commercial and clinical products in global markets. The incumbent will be responsible for overseeing the global regulatory strategy of assigned products, assuring they are aligned with Health Authority expectations and assuring that regulatory submissions are on time and high quality. Additional duties include coordination with our global manufacturing sites, global dossier compliance, Life Cycle Management projects, planning support and integration of regulatory strategy with those sites and communication to senior management. The position will lead, supervise and coach a team of globally based regulatory professionals and be responsible for their development. The role will also support other CMC projects and teams as needed. Experience working in a matrix environment and excellent people skills are required.

Major Activities/Key Responsibilities

  • Leads and manages an RA CMC Team

  • Supports Global RA objectives

  • Supports the Head of Global RA CMC Biologics

  • Contributes to global strategy and planning decisions

  • Manages team and develops staff

Directs RA CMC teams and provides senior strategic leadership in the following areas

  • New applications for drugs/devices                                            

  • Plan/Prep/Submit/Review support

  • CTA / IND preparation and maintenance

  • BLAs

  • NDAs

  • License Maintenance                                                                  

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

  • Post-Marketing Commitments (PMCs) and Other Regulatory Commitments (ex. Stability data, from CTD text

  • Assemble Information, including assigned deliverables

  • Direct frequent face to face meeting with global health authorities

  • Initiate Communication to Responsible Parties and Stakeholders

  • Compile monthly summary update of PMCs and other regulatory commitments related to Sites for CQO

  • Track Internal Progress and assemble final package

  • Submit to Agency/Health Authority/Affiliate

  • Update data management systems

  • Issue Follow-up Communications to Responsible Parties and Stakeholders as necessary

  • Track Agency/Health Authority Progress

  • Close out Commitments in appropriate databases when Agency/Health Authority Indicates it has been fulfilled

  • Communicate Close Out of Commitment to All Parties

  • Point of contact with Global Reg Affairs Product Leads

  • Interaction/liaise with FDA, Health Canada, ANVISA, PMDA and many others onproduct topics

  • Post Approval Supplements                                                                    

  • Regulatory strategy development

  • Preparing / Authoring Submissions – US

  • Preparing / Authoring Submissions – ROW

  • Review of submissions

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

  • Notify Reg Ops for publishing and dispatch to BoH

  • BoH Response to Query – US, EU, ROQ

  • Change Controls                                                                                    

  • Manage GRA component of change control assessments – LCR in site system (TW)

  • If change affects multiple products, discuss and agree on global requirements

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

Basic Qualifications:

  • Advanced degree (PhD preferred) with 10/15 years’ experience.

  • Expert knowledge of EMA and FDA regulations is essential.

Preferred Skills:

  • Proficient in MS Word, Excel, PowerPoint, MS Project, and database systems.

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

  • Demonstrated ability to work successfully on project teams.

  • RAC certification or equivalent preferred.

  • Previous experience working in a fast paced very high-pressure environment on multiple productlines

  • Manufacturing, QA/QC experience a plus

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

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.


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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