Director Regulatory CMC
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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
CTA / IND preparation and 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
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.
Advanced degree (PhD preferred) with 10/15 years’ experience.
Expert knowledge of EMA and FDA regulations is essential.
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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