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Leader Regulatory

Waltham, Massachusetts

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.

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Rewards

  • HEALTH AND WELLNESS PROGRAMS

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • EMPLOYER MATCHING

    Employer matching because Sanofi invests in their employees!

  • PROFESSIONAL DEVELOPMENT

    Sanofi is eager to further your development and expertise in an ever challenging environment.

  • FAMILY SUPPORT

    Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.

  • PAID TIME OFF

    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

  • WORK/LIFE BALANCE

    Importance of life outside of the office is valued at Sanofi.

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Responsibilities

The Associate Director is responsible for the review of materials related to labeling, advertising and promotion of all products as assigned. Support the compliance with internal SOPs and health authority regulations, including compilation and submission of any required documents to regulatory agencies.

Essential functions:

  • Maintains up-to-date knowledge of laws, regulations and policies enforced by the regulatory authorities. as they relate to labeling, advertising and promotion of pharmaceuticals
  • Responsible for training and monitoring the commercial and medical teams on regulations governing advertising and promotion
  • Serve as a liaison with Health Authorities (e.g., FDA APLB, OPDP) and review/submit materials to appropriate agencies
  • Provide regulatory advice, review and approve advertising/promotional materials and other materials (i.e. Corporate communications, press releases, etc)
  • Works collaboratively with internal customers; including commercial, legal and medical as part of the Product Review Committee (PRC)
  • Coordinates and leads PRC meetings and ensures implementation of an efficient and compliant PRC process
  • Support the development of department SOPs or work instructions
  • Provide leadership for effective decision-making, planning, and project management
  • Clearly and efficiently analyze issues and communicate options in the face of ambiguity

Experience/Qualifications:

  • Experience in interpreting regulations, guidelines, policy statements, is required including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to advertising and promotions
  • Strong interpersonal skills with strong sensitivity for a multicultural/multinational environment
  • Ability to foster effective, positive interactions with cross-functional partners
  • Ability to maintain optimism and energy in the face of change and adversity and take ownership for the consequences of difficult decisions
  • Ability to influence cross functional teams, committees and attain group goals
  • Demonstrated leadership and communications skills
  • Well organized, detail oriented, effective written and oral communications skills
  • 5+ years pharmaceutical/biotechnology industry experience in advertising and promotions
  • Bachelor’s degree in Biology or Chemistry, PharmD

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.

#LI-GZ

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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  • Regulatory Affairs, Waltham, Massachusetts, United StatesRemove