Regulatory Associate

Job description

Position Description: Senior Associate, Regulatory Affairs

Job Duties and Responsibilities:

·  Management and conduct of the Global regulatory activities for assigned projects in line with regulatory requirements.  
·  Provide Global Regulatory Strategy support as needed on development and marketed products. This support will include both strategic and operational activities.
·  Preparing, compiling, reviewing and processing the regulatory submissions including both pre-approval and submissions such as IND, NDA/BLA, MAA, amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, etc.
·  Coordinating and consulting with other concerned functions on the content, and assembly of regulatory documentation and ensuring consistency, completeness and adherence to standards for all the regulatory submissions.
·  Attending and participating in the assigned project/regulatory product development and submission teams, providing clear and consistent regulatory recommendations.
·  Assist with regulatory communications with the FDA for assigned products and activities, including preparing the FDA meeting requests, briefing book, meeting rehearsals/slides, meeting minutes of the FDA meetings and the generation of responses to the FDA queries.
·  Support the compilation, development, submission, and maintenance of worldwide regulatory filings;
·  Track regulatory project status and informational documents
·  Coordinate required documentation in coordination with CMC Team or Functional group
·  Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time
·  Interfacing with global Regulatory partners and internal cross functional teams
·  Attending relevant functional area and project team meetings as required

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Education and Experience:

·  BS minimum, Master of Science preferred
·  1-2 years of industry experience with regulatory preferred

Qualifications

·  NDA, BLA/IND/CTA experience
·  Project Management Experience 
·  Regulatory Operations 
·  Organized
·  Direct experience in Regulatory operations, coordinator 
·  Fundamental Knowledge to compare documents with Federal Standards 

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.

#GD-SA

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.