Regulatory Affairs Specialist: Pharmaceutical Compliance Expert
hace 3 semanas
In the pharmaceutical industry, compliance with regulations is critical for the success of any project. As a Regulatory Affairs Specialist, you will play a key role in ensuring that our company, ProductLife Group, meets all regulatory requirements in Mexico and Central America.
Responsibilities:- Provide guidance and support on Mexican and Central America legislation
- Contribute to pre-licensing activities, new registration, and post-licensing regulatory submissions
- Produce client administrative documents for regulatory submissions
- Compile regulatory dossiers according to national requirements
- Manage systems and administration
- Track and document regulatory submissions and authority approvals
- Support clients and associate companies on regulatory issues
- Liaise with sponsor head-office and affiliate departments on regulatory matters
- Review packaging texts and format summaries of product characteristics
- Bachelor's degree in a Life Sciences field or equivalent
- 5+ years of experience in Regulatory Affairs in the pharmaceutical industry or as a service provider
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