Regulatory Affairs Manager
Regulatory Affairs Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Manages most aspects of company regulatory interface with domestic and international health authorities.
- Manages the development and deployment of the regulatory program that ensures aggressive product approval.
- Manages and may generate regulatory submission documents for new products or changes to existing health authorities filings including domestic and international submissions and registration.
- Manages the submissions of clinical study submissions.
- Determines governmental regulations affecting company processes and assures the processes are complete and accurate to ensure company compliance.
- Partners with various teams throughout organization (Clinical Operations R&D Quality etc.) on projects.
- Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations.
- Provides guidance with localization and labelling requirements.
- Manages regulatory reporting.
- Bachelors or advanced degree preferred (M.S. Pharm.D. M.D. Ph.D.) in a scientific discipline.
- 5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
- Strong analytical and problem-solving skills.
- Strong written and verbal communication skills including the ability to interact effectively and to influence.
Employment Type
Full Time
