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Sanofi Group EuroAPI Regulatory Associate in Bridgewater, New Jersey

JOB RESPONSIBILITIES:

  • Coordinates & maintains registration dossiers required for the EuroAPI Sales activity in North America (US & Canada).

  • Manages Regulatory Affairs (RA) in accordance with local regulation and Sales strategy.

  • Contributes to EuroAPI Quality & Regulatory network with Global organization, manufacturing sites and Health Authorities.

  • Contributes the regulatory operations and business processes to support activities locally, acting as customer interface.

  • Records of key Regulatory processes and reports KPIs for Customer Excellence policy and regulatory compliance.

  • Participates to the Quality Management System of EuroAPI US legal Entity

  • Help manage QA aspects relative to distribution of products marketed in North America such as distribution deviation, complaint, 3PL management, etc.

  • Development of new registrations and maintenance of EuroAPI North America portfolio:

  • Manages Regulatory Policy of the zone in relation with Regulatory Global functions.

  • Reviewing CMC content as well as drug and drug substance manufacturing change controls to translate the knowledge into review and preparation of documents needed for submission.

  • Life-cycle management of around 65 DMFs by Reviewing submission documents and communicate outstanding requirements with the sites to ensure satisfaction of FDA electronic eDMF requirements and internal Sanofi processes.

  • Ensure the Regulatory compliance of the DMF registered in the region.

  • Review and submit submissions such as Annual reports, CBEs, CBE-30s and PAS’s.

  • Ensures annual reports are submitted at the due date.

  • Provides advice to the manufacturing sites when needed to answer to questions from Health Authorities (HA).

  • Actively contributes to the Change Control process as soon as North American Region is concerned.

  • Ensures adequate management of registration dossiers portfolio and dossier submission according agreed planning (Regulatory LRP).

  • Participates to the Quality Management System of EuroAPI US legal Entity

  • Applies global SOP dealing with distribution activity in EuroAPI US Legal Entity:

  • Writes and approve local SOP/instruction relative to distribution activity of euroAPI US

  • Trains newcomers in EuroAPI US legal entity about GDP rules, IT tools and global SOP for distribution

  • Support QA aspects relative to relative to distribution of products marketed in North America such as distribution deviation, complaint, 3PL management (transportation and warehousing), …

  • Manage requests relative to distribution failure (on out-bound materials shipped either by indent or ext-stock flow and on in-bound materials) raised in US market.

  • Manages the 3PL relationship as Quality first contact for any quality request, warehouse deviation and capa, QAA revisions, product list revisions and customer request to audit 3PL warehouse

REQUIREMENTS:

Education / Experience:

  • Education: University degree in Pharmacy, Chemistry/ Biochemistry, regulatory affairs.

  • Experience: Minimum of 5 years in the pharmaceutical industry with knowledge in Regulatory Affairs and Quality Assurance.

  • Knowledge of North America Regulations: US FDA, Health Canada.

Technical Kkills & Competencies / Language

  • Background in regulatory activities

  • English Speaking

  • GMP expertise

Soft Skills & Required Behaviors:

  • Ability to work and manage tasks in a cross-functional way

  • Good problem-solving skills, analytical thinking

  • Constructive and effective communication skills

  • Flexible / Entrepreneurial mindset

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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