21 sep
|
Empresa Confidencial
|
México
21 sep
Empresa Confidencial
México
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 Integral 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.
Location: Mexico City
Work model: Hybrid
📌 Gerente de Asuntos Regulatorios (México)
🏢 Empresa Confidencial
📍 México