Regulatory Affairs Specialist generating regulatory submissions and managing compliance for medical device engineering projects at Teleflex. Ensuring adherence to FDA and Health Canada regulations with effective project timelines.
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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