Senior GRC Engineer focusing on protecting customer and enterprise data at Genesys. Leading security assessments and compliance with cloud security frameworks in a global context.
About the role
- Senior Manager of Regulatory Affairs responsible for regulatory guidance and strategy in biosimilar development. Work with management to ensure quality and efficient submissions.
Responsibilities
- Provide regulatory guidance to product development
- Support and review CMC sessions in submissions & deficiency responses
- Develop regulatory strategies for projects and portfolios of biosimilars
- Prepare and review communication documents & submissions to agencies
- Manage the regulatory aspects of products and projects
- Track and interpret FDA new guidances & new requirements
Requirements
- Master or Ph.D. degree in life sciences
- Over 6 years related experience in product development and/or regulatory CMC
- Expertise in and experience with the development of biologics and/or biosimilars
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Benefits
- Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.
- Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.
- Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.
- Professional Growth: We offer ample opportunities for professional development and career advancement.
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