Regulatory Affairs Leader is responsible for actively contributing to labeling development for development and commercial products.
Prepare corporate labeling documents (Core Data Sheet or Core Safety Information), US and EU Summary of Product Characteristics and patient leaflet for development projects and marketed products within the framework of regulatory submissions to obtain internal approval, new Marketing Authorizations or to update existing Marketing Authorizations
Lead the development and implementation of regulatory labeling strategy for assigned projects and programs, specifically for the development and maintenance of labels.
Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects and programs. This includes coordinating cross functional labeling team meetings, preparation of labeling components for supplements, and participating in labeling discussions with health authorities resulting in product approvals or labeling updates.
Prepare and deliver effective presentations for external and internal audiences.
Work is performed under general direction. Demonstrate effective cross-functional skills. Capable of strategic thinking and risk assessment for area of responsibility. Demonstrate good communication skills (oral/written/listening). Ability to impact and influence the decisions of a team.
Experience in interpreting regulations, guidelines, policy statements, etc, is required including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to labeling and communications. In-depth working knowledge of labeling, guidance, and agency regulatory action history is required
Strong interpersonal skills with strong sensitivity for a multicultural/multinational environment
Ability to foster effective, positive interactions with cross-functional partners
Ability to influence cross functional teams, committees and attain group goals
Demonstrated leadership and communications skills
Experience and knowledge in preparation of regulatory submissions with explicit practical experience relevant to promotional communications
Well organized, detail oriented, effective written and oral communications skills
5 years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 2 years’ experience in Regulatory Affairs
BA/BS/University Degree required, Life/Health Sciences preferred.
Sanofi US Services, 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.
Junior industry position
Waltham , United States