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Senior Director GRA CMC Biologics

Bridgewater, NJ;Westborough, MA

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.

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  • PAID TIME OFF

    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

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Responsibilities

Job Description

This position will lead the Regulatory aspects of Chemistry, Manufacturing and Controls (CMC) for licensed and clinical biological proteins. This position will develop and lead the product strategy and oversee the direction of approximately 13 commercial and 7 clinical products in distributed in 60 plus countries. Incumbent will be responsible for overseeing the global regulatory strategy, assuring it is 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, and integration of regulatory strategy with those sites and communication to senior management.

Lead, supervise and coach a team of approximately 21 US-based regulatory professionals and be responsible for their development.

Lead other CMC projects 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 Vice President and 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)
  • Site renewals (ex. Japan Accreditation)
  • 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
  • Initial 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 Commitment in IRiS 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 on  product 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
  • BoH Response to Query – EU
  • BoH Response to Query – ROW
  • Change Controls                                                   
  • 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 preferred
  • Expert knowledge of EMA and FDA regulations is essential.

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 very high pressure environment on multiple product   lines
  • Manufacturing, QA/QC experience a plus

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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