REGULATORY AFFAIRS MANAGER | PHARMACEUTICAL INDUSTRY We are looking for a Regulatory Affairs Manager to join the team of a leading multinational pharmaceutical company.
Key Responsibilities
- Develop and execute regulatory strategies in alignment with business and compliance objectives. - Lead regulatory submissions, registrations, renewals, variations, and lifecycle management activities. - Ensure compliance with applicable local and international regulatory requirements. - Collaborate cross-functionally with Medical, Quality, Supply Chain, Commercial, and General Regulatory teams. - Maintain strong relationships with health authorities and support regulatory inspections and inquiries. - Provide regulatory guidance for new products, launches, and portfolio activities. - Monitor regulatory changes and assess their potential impact on the business.
Requirements
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry,
Biology, or a related field. - Minimum 3 years of experience in Regulatory Affairs within the pharmaceutical industry. - Experience with regulatory submissions and health authority interactions. - Strong knowledge of applicable pharmaceutical regulations and compliance requirements. - Advanced English proficiency. - Strong communication, project management, analytical, and stakeholder-management skills. - Ability to work effectively in a multinational and cross-functional environment.
What we offer
- Opportunity to join a leading multinational pharmaceutical organization. - International and cross-functional exposure. - Professional growth and development opportunities. - Competitive compensation and benefits package.
📌 Gerente de asuntos regulatorios (Nezahualcóyotl)
🏢 Empresa Confidencial
📍 Nezahualcóyotl
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