Technical Manager

Celltrion Inc; Ciudad de México; Presencial; MXN 60,000 - 80,000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Mexico City is seeking a Technical Manager to oversee regulatory compliance and quality control activities. Responsibilities include managing regulatory submissions for product approval and ensuring ongoing compliance with quality standards. The ideal candidate will have a degree in life sciences, strong knowledge of regulatory processes, and excellent communication skills. This role is crucial for maintaining product integrity and liaising with both internal teams and regulatory agencies.

Formación

• Extensive knowledge of regulatory processes for pharmaceuticals.
• Experience in quality management systems.
• Strong communication skills to liaise with regulatory authorities.

Responsabilidades

• Manage regulatory activities for marketing authorization.
• Monitor the effectiveness of pharmaceutical products.
• Oversee Quality Control activities and internal audit schedules.

Conocimientos

Regulatory compliance

Pharmacovigilance

Quality control

Scientific communication

Educación

Degree in life sciences or related field

Descripción del empleo

At Celltrion Healthcare Mexico, we are looking for our new Technical Manager who will be responsible for representing our company before regulatory entities. The main responsabilities include:

• Management of all regulatory activities to achieve Marketing Authorization of pharmaceutical products with Local Regulatory Agency.
• Ensure all products receive prompt regulatory approval.
• Responsible for the monitoring and reporting of the effectiveness and any adverse effects or side effects of pharmaceutical products on the market in the general population and in hospitals and research trials.
• Ensure that products are utilized effectively, serve as scientific peers and resources within the medical community, and are scientific experts to internal colleagues at companies
• Implement Celltrion quality requirements, ensuring ongoing product quality and regulatory compliance.
• Oversee Quality Control activities, including coordination with internal teams and external service providers, review of quality documentation, and management of deviations, CAPAs, and quality-related issues.
• Maintain a regular conversation with Celltrion headquarters and the rest of the LATAM region in order to provide regular updates on regulatory of status.
• Ensure the implementation of internal audits as well as scheduling audits and respond to findings and implementing corrective actions found on audits.
• Identify compliance risks to current regulations and will guided the planning and execution of quality assurance improvements.
• Review all marketing materials prior to promotion to comply with the local policies on advertising and promotion of registered products;
• Conducting basic pharmacovigilance training, basic pharmacology and pharmacokinetics of the product to medical representatives of the company and to the other company.
• Handling medical information enquiries from both in-house and external customers and healthcare providers.
• Act as channels of information about new research developments, clinical trial activities and therapeutic approaches therefore involves presenting information to pharmaceutical product teams and marketing new therapeutic products to physicians and other healthcare professionals.