We are seeking a highly motivated and experienced Regulatory Affairs Manager to join our dynamic team.
The Regulatory Affairs Manager will play a pivotal role in ensuring our pharmaceutical products comply with all relevant regulations and standards.
This position offers the opportunity to work on cutting-edge projects and make a significant impact on the success of our company.
Key Responsibilities
Develop and implement regulatory strategies to ensure product approvals, registrations, and compliance with local, regional, and international regulatory requirements.
Serve as the primary liaison with regulatory authorities, including the FDA, EMA, and other relevant agencies, to facilitate efficient communication and negotiate approvals.
Monitor and interpret changes in regulations, guidelines, and industry trends to ensure the company's products remain in compliance.
Provide regulatory guidance to cross-functional teams.
Collaborate with the quality assurance team to maintain and improve the quality management system (QMS) to meet regulatory requirements.
Manage and mentor a team of regulatory affairs professionals, fostering their growth and development.
Maintain accurate and up-to-date regulatory documentation and records, ensuring they are accessible for audits and inspections.
Número de vacantes: 1
Modalidad de trabajo: Presencial
Tipo de contrato: Indefinido
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**Requisitos**
Bachelor's degree in pharmacy, pharmaceutical sciences, life sciences or similar.
A minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
In-depth knowledge of pharmaceutical regulations, including FDA, EMA, and ICH guidelines.
Strong leadership and communication skills, with the ability to work effectively in cross-functional teams.
Experience in preparing and submitting regulatory documents.
Excellent organizational skills and attention to detail.
C1 in English, both written and spoken.
en Ciencias de la Salud
Estudios mínimos
Licenciado
**Idiomas**:
Inglés nível Alto.
- Experiência mínima
5 años
Disponibilidad para viajar
Ninguna