Regulatory Affairs Analyst
Regulatory Affairs Analyst
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Purpose
Act as responsible for obtaining and maintaining Theramex product registrations and licenses in compliance with COFEPRIS regulations. Collaborate with our headquarters and coordinate third parties related to regulatory affairs.
Key Duties and Responsibilities
- Prepare review and submit registration for new products (focus on synthetics and biologicals)
- Prepare review and submit postregistrations and changes
- Manage product lifecycle
- Be aware of national legislation and its updates
- Review and approve promotional materials
- Review and approve package materials
Minimum Requirements (Experience & Education)
- Pharmacy degree
- At least 3 years of professional experience with drug registration and postregistration
- Advanced English
- Reliability responsibility organization commitment flexibility proactivity
- Solid knowledge in evaluating technical documentation for the preparation of registration dossiers creation and submission of registration and postregistration processes toCOFEPRIS
Employment Type
Full Time
Company Industry
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
