Sr. Regulatory Affairs Manager
País São PauloCONTRACTOR
Consultor Lucas Padilha
Referência da vaga R67PY2
Data de postagem 10 de Junho de 2022são-paulo-sp health-&-life-sciences/sales 2022-06-14 2022-07-10 health-and-safety São Paulo BR Robert Walters https://www.robertwalters.com.br https://www.robertwalters.com.br/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
We are proud of the contribution each of us makes to improving patients’ lives with our innovative and advanced medical solutions. We hire individuals who are looking for a career and more than just a job. Every role at our company plays a part in our success and we are currently seeking to fill a role on our Regulatory Affairs team. If you are looking for a career with a company where you can be a part of a passionate team of dedicated people, we strongly encourage you to apply today!
- Develops global regulatory strategies and risk assessments for marketed products in collaboration with other parts of GRA.
- Assures effective involvement with change control systems.
- Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.
- Assures that appropriate contacts with Health Authorities , in collaboration with Country Regulatory Groups , are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships.
- Responsible for direct contact/liaison with US FDA and EMA on specific CMC topics.
- Supports strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS).
- Manages or directly contributes to the CMC preparation, review and approval of regulatory CMC dossiers for submission in collaboration with, Industrial Affairs Functions and GRA Regulatory Operations.
- Assures that submission dossiers meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved.
- Assures that technical and regulatory CMC issues are appropriately resolved with optimal solutions.
- As applicable, support the regulatory inspection process for development projects and marketed products.
- Contributes knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate Sanofi visibility and input is recognized.
- Monitors the review of local and international Health Authority regulations and guidelines, contributes to the commenting process and/or develops position papers.
- Assures that current Health Authority thinking and trends (paradigm shifts) are understood and broadly communicated.
- Minimum of a Bachelor's Degree; advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable.
- Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is required.5 years of direct Regulatory CMC experience is preferred
Experience working for a Regulatory Health Authority is helpful but not essential.