Regulatory Affairs- Oncology GRTL
Cambridge, Massachusetts, Amsterdam, Netherlands, Cambridge, United Kingdom, Naarden, Netherlands
Job Purpose/Job Description:
The Global Regulatory Lead is part of the Global Regulatory Affairs (GRA) team within the MPSM Global Business Unit (GBU). she is responsible for acting as the global regulatory lead responsible for executing the maintenance activities for their assigned products within the oncology portfolio. Additionally, she will act as the global regulatory lead responsible for developing/facilitating product regulatory strategies and presenting to the appropriate governances as applicable.
Major Activities/Key Responsibilities
- Lead a portfolio of marketed products for assigned Therapeutic Area (TA) by actively contributing to the development and implementation of regulatory strategies and timelines
- Lead and/or represent GRA on Global Regulatory Teams and/or GBU project teams
- Interact with a cross-functional team in the collection, review and assembling of the scientific, clinical, manufacturing and administrative section documents for global submissions to regulatory authorities
- Ensure the appropriate peer review of key regulatory documents and submissions across programs in the portfolio
- Represent the assigned product and/or TA towards Senior GRA Management and other governance bodies (i.e., sub-Safety Management Committee (SMC), Benefit Risk Advisory Committee (BRAC), etc.)
- Proactively identifies and communicates to higher management all potential risks and options for issue resolution (e.g. maintenance issues, submissions, etc.)
- Research and analyze regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes
- Recommends improvements to operating policies/processes
- Ensure compliance with all internal and external requirements and procedures
- Maintain professional working relationships with colleagues, fostering collaboration and idea sharing.
- Be the GRA representative for Digital initiatives across GRA Global Health and EP organization.
- Ensure GRA Excellence activity and simplify WOW on Global Health business portfolio
- Communicate within GRA GH team the WHO regulation update
Impact on the organization
Ensures that projects are completed in line with the Blueprint principles and are on schedule and within budget. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional resources.
- Bachelor's degree in Regulatory Affairs or relevant degree. Preferred: Master’s, PharmD, PhD degree
- and a minimum of 3 years in Regulatory Affairs or relevant industry experience
- Demonstrated ability to prioritize multiple projects
- Strong multicultural awareness is a must
- Excellent communication and organizational skills as well as attention to detail
- Ability to work in a matrix team environment with strong interpersonal skills (collaborative, tactful and diplomatic)
- Motivated, self-starter
- Proficient in MS: Word, Excel, Powerpoint and Project
- Sense of urgency and perseverance to achieve results and deadlines
- Knowledge/experience with Manufacturing, QA/QC and/or clinical development experience also a plus
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.
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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