Regulatory Affairs Specialist LATAM - Lima

We are recruiting a Regulatory Affairs Specialist LATAM, based at our affiliate in Lima. Reporting to the Regional Regulatory Affairs Head / International, your mission is to ensure compliance with corresponding regulations and drive the successful execution of regulatory strategies, while actively engaging in both corporate projects and regional initiatives.

Your main responsibilities are as follows:

• Develop and execute regulatory strategies ensuring compliance with applicable guidelines and directives, with a particular focus on LATAM legislation developments
• Take ownership of assigned regulatory projects (Corporate and/or Regional), acting as the main point of contact and ensuring the planning, coordination, and timely execution of all regulatory activities with partner companies
• Manage preparations and follow up for new marketing authorizations and lifecycle maintenance (e.g. renewals, variations, line extensions) within the assigned territory
• Prepare and manage local labelling documents in line with Company Core Data Sheet and national requirements
• Collaborate with internal stakeholders (Packaging, Pharmacovigilance, Quality, etc.) to ensure compliance and alignment across projects following OM´s policy
• Represent Regulatory Affairs in cross-functional teams and relevant meetings
• Maintain accuracy and completeness of entries in the Regulatory Information Management System according to internal guidelines
• Support business performance improvements by optimizing time-to-market and accelerating product change implementation

To carry out this mission, we are looking for a person with the following profile:

• University degree in Life Sciences or a related field; advanced degree in Pharmaceutical Science an asset
• At least 3 years of experience in Regulatory Affairs in the LATAM Region, with a proven track record of collaborating with external partners, preferably within the pharmaceutical industry
• Ability to analyze the regulatory requirements and perform comprehensive gap assessments
• Fluent in English and Spanish, both written and spoken
• Proficiency in MS Office; familiarity with Veeva Vault desirable

You possess an analytical and results-driven mindset, excelling in dynamic environments where adaptability is crucial. Your work is marked by accuracy, proactivity, and the ability to manage tight deadlines while maintaining confidentiality. You also possess strong communication skills, a collaborative mindset, and intercultural competence, enabling you to engage effectively with diverse stakeholders.

Ready to make a difference? Apply today and embark on a rewarding journey!

About Us

OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections. 
The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.

For more information, visit the website: ompharma.com.