Regulatory Affairs Manager
hace 15 horas
Solventum is seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico. As a Regulatory Affairs Specialist, you will be responsible for providing general regulatory support for medical products sold in Mexico, including managing medical product licenses with COFEPRIS, reviewing and approving product labeling and advertisements, and compiling and submitting dossiers for new product registrations or maintenance of current registrations in country.
The Impact You'll Make- Provide regulatory support for medical products sold in Mexico;
- Manage medical product licenses with COFEPRIS;
- Review and approve product labeling and advertisements to ensure alignment with country regulations;
- Compile and submit dossiers for new product registrations or maintenance of current registrations in country;
- Follow business Standard Operating Procedures (SOP's) regarding specific regulatory activities and track with consultants and distributors;
- College degree in pharmaceutical, chemical, biological, medical, biomedical, biochemical areas or related to Chemistry (BSc) or science career;
- Professional License Number and certificate issued;
- Written and verbal fluency in both Spanish and English Language;
- 5 years of experience in medical product regulatory affairs space, specifically as it relates to Mexico and COFEPRIS requirements & procedures;
Hybrid/Remote Eligible
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