Location
Bridgewater, NJ | United States
Job description
Job Overview:
The Labeling Manager will report to the Global labeling Business Unit head.
The Labeling Manager will be responsible for the labeling of a portfolio of marketed products and projects under development.
Job Responsibilities:
Support cross-functional teams as a labeling expert and contribute to the definition of global regulatory strategies and to the preparation of submission dossiers or responses to Health Authorities :
Prepare corporate labeling documents (Core Data Sheet or Core Safety Information), US and EU Summary of Product Characteristics and patient leaflet for projects and marketed products within the framework of regulatory submissions to obtain new Marketing Authorizations or to update existing Marketing Authorizations. To take into account and assess development study reports, pharmacovigilance data (post-marketing) and any other scientific reports. Approve final proof of labeling artworks according to established responsibilities.
Support local countries in implementing labeling changes,
P ractical experience in Regulatory Affairs, Pharmacovigilance, Medical Affairs or clinical development. Education: Physician, Pharmacist, Veterinarian or Life Sciences Degree
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Specific Requirements:
Knowledge and experience in European regulations and international regulatory environment,
Minimum education level required is PharmD, PhD, MD or equivalent advanced degree
Five (5) years of pharmaceutical experience within regulatory affairs required
Skills: Excellent written and verbal communication skills, negotiation skills, demonstrated ability to solve problems and proactivity, ability to work with multifunctional and culturally diverse teams, organizational skills, ability to manage multiple projects at short notice, excellent inter-personal skills, autonomy, rigor, fluent business English.
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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