US Regulatory Lead, Manager/Senior Manager

Company: Sanofi
Location: Bridgewater
Posted on: April 8, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the--Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our--colleagues will explain how these tools will be used throughout the recruitment process and will be on hand to answer any questions you might have. US Regulatory Lead, Manager/Senior Manager From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner. Do you have what it takes for a successful career with Sanofi? The role is primarily responsible for providing US regulatory strategic and tactical support for both development and marketed products for the GBU. In this capacity, the Manager/Senior Manager North America GRA will be responsible for providing US regulatory advice for development programs and marketed products working either independent from or with the North American (NA) Regulatory Lead, the Global Regulatory lead (GRTL) and Global Regulatory Team (GRT) (regions, Regulatory CMC, Regulatory Operations, EU authorized representatives, labeling). The role may be a North American Regulatory Lead for products that are early in pharmaceutical development or assigned to perform tasks associated with routine regulatory application maintenance. For projects where the role is assigned as the NA RL, person will sit on GRTs. Competencies for Success: Strategic & Technical Regulatory Affairs Expertise: Excellent operational strategy and writing skills. Experience with preparation and requirements of initial INDs, CTAs, amendments, DSURs and/or meeting briefing documents. Experience with BLA, NDA, or MAA a plus. Understanding of the development of drugs and/or innovative biologics products. Experience in orphan drugs a plus. Basic understanding of regulations and guidelines related to drug development and registration is required. Ability to work effectively in a collaborative team environment where results are achieved through influence, communication and the incorporation of multiple points of view. Other Personal Characteristics: High standards of integrity. Strong interpersonal skills. Excellent oral and written presentation skills. Dedicated and persuasive "can-do" attitude. Independently motivated, detail oriented and good problem solving ability. Self-motivated; entrepreneurial spirit; excellent time management skills. Organizational savvy; be able to work in a highly matrix structure including sharing knowledge with relevant stakeholders. "Think out of the box" mindset. Basic Qualifications: BS in pharmaceutical related scientific field. Minimum 1-3 years of regulatory experience in a biotech/pharma company. Demonstrated ability to handle multiple projects is required. Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities. Excellent communication skills and ability to influence across multiple functions. Regulatory Certification (RAC) (optional). 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 #LI-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. Join our Talent Network and get Sanofi communications delivered to your inbox. By submitting your information, you acknowledge that you have read our privacy policy and consent to receive email communication from Sanofi.

Keywords: Sanofi, Trenton , US Regulatory Lead, Manager/Senior Manager, Executive , Bridgewater, New Jersey