Coordinator, GRA, LRR Mexico, Region LATAM & Partner Business

The Opportunity: Reporting to the Associate Director, Regulatory Affairs & Pharmacovigilance of our Mexico sales affiliate, as the Local Regulatory Responsible (LRR) Mexico, Region LATAM & Partner Business, you will focus on local regulatory requirements and Health Authority national engagements. You will be responsible for new product registration, product lifecycle maintenance (variations, renewals), obtaining import licenses and local product batch release. You will also manage the evaluation of advertising materials and mainly focus on biological, biotechnological, and orphan drug products. This is a hybrid role, which offers a combination of an onsite and remote work schedule. The Role: Regulatory Activities: - Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities; monitor and report progress consistently to stakeholders.
- Stay updated on local regulatory requirements, guidelines, and indu...