Senior Specialist Regulatory Affairs (Oncology)

Merck; México; Presencial; MXN 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

Merck in Mexico is seeking a Regulatory Affairs Manager (Senior Specialist) to lead timely preparation, submission and follow-up of new Marketing Authorization applications with COFEPRIS, and to maintain regulatory status through variations, renewals, and post-approval changes.

The role requires strong regulatory strategy, cross-functional collaboration, and English proficiency to coordinate with regional teams and external authorities.

Formación

• Degree in Pharmacy, Life Sciences, or a related field, or equivalent qualification.
• Minimum of 8 years of experience in a Registration Department or equivalent role, including interactions with COFEPRIS.
• Strong knowledge of local legislation, procedures, and guidelines governing pharmaceutical products.
• Excellent verbal and written communication skills.
• Strong organizational and planning abilities.
• Experience in Oncology is required, Biological, Biotechnological, small molecules, etc.
• High attention to detail, adaptability, and the ability to manage multiple priorities under tight deadlines.
• Disciplined, proactive, and able to coordinate tasks effectively across teams.
• Ability to navigate complex regulatory environments with diplomacy and assertiveness when engaging with internal and external stakeholders.
• Proficiency in English.
• Client-oriented mindset aligned with our company´s leadership vision.
• Focus on results, strategic planning, accountability, and execution excellence.

Responsabilidades

• Ensure the timely and high-quality submission of new MA applications.
• Lead the approval process by managing regulatory authority queries related to product registrations and major indications, and proactively negotiate to achieve optimal regulatory outcomes.
• Develop and execute local action plans to support the successful authorization, launch, and lifecycle integration of newly approved products.
• Ensure assigned marketing authorizations remain compliant with regulatory requirements by executing variations, renewals, and related activities within established timelines and standards.
• Communicate approval updates to relevant stakeholders through appropriate channels.
• For major indications, design and implement local action plans aligned with the process for new MA applications.
• CMC Post Approval Changes, variations, renewals, labelling and in general Product Life cycle management regulatory applications.
• Provide internal stakeholders with accurate and up-to-date information on the regulatory status of assigned products.
• Ensure proper use of the Artwork Management System to support efficient artwork creation and revision processes.
• Implement and maintain regulatory databases and systems in compliance with local requirements and internal standards.
• Maintain complete, accurate, and up-to-date regulatory files and archives.
• Contribute to the development, implementation, and continuous improvement of SOPs to ensure compliance with applicable regulations.
• Support the implementation of updated regulatory documentation in alignment with agency requirements and internal policies.
• Address regulatory process-related issues, ensuring timely resolution.
• Conduct investigations in accordance with our company standards and local procedures.
• Collaborate closely with local teams on key regulatory activities, including Quality Notifications, GMP inspections, vaccine release documentation, and Annual Product Reviews.
• Ensure the timely availability of packaging materials, including package leaflets and other artwork, in compliance with Artwork Management procedures and established timelines.
• Coordinate timely and appropriate actions related to deletions, divestitures, and acquisitions.
• Participate in subsidiary product and launch teams, providing regulatory guidance.
• Monitor and evaluate new and emerging regulations, as well as proposed changes, assessing their potential impact on business and operations.
• Represent the company in task forces organized by the pharmaceutical industry and regulatory agencies, contributing to policy discussions and regulatory strategy.

Conocimientos

Adaptability

Audits Compliance

Detail-Oriented

Drug Regulatory Affairs

Employee Training Programs

Global Communications

Pharmaceutical Regulatory Affairs

Pharmacovigilance

Process Improvements

Projec

Educación

Degree in Pharmacy, Life Sciences or related field

Descripción del empleo

We are looking for a Regulatory Affairs Manager (Senior Specialist) to join our Regulatory Team in Mexico.

Position Overview

The Regulatory Affairs Manager will be responsible for ensuring the timely preparation, submission, and follow-up of new Marketing Authorization applications with the Health Authority. This role also ensures the maintenance of the regulatory status of assigned products through the timely submission of variations, renewals, and post-approval changes.

The successful candidate will stay current on pipeline submissions, applicable local regulations, and evolving guidelines, proactively developing and implementing regulatory strategies as needed. In addition, this role requires building and maintaining strong collaborative relationships with internal and external stakeholders, including regional functions and regulatory authority ( Cofepris) .

Key Responsibilities

New Marketing Authorization (MA) Applications

• Ensure the timely and high-quality submission of new MA applications.
• Lead the approval process by managing regulatory authority queries related to product registrations and major indications, and proactively negotiate to achieve optimal regulatory outcomes.
• Develop and execute local action plans to support the successful authorization, launch, and lifecycle integration of newly approved products.

Maintenance of Marketing Authorizations

• Ensure assigned marketing authorizations remain compliant with regulatory requirements by executing variations, renewals, and related activities within established timelines and standards.
• Communicate approval updates to relevant stakeholders through appropriate channels.
• For major indications, design and implement local action plans aligned with the process for new MA applications.
• CMC Post Approval Changes, variations, renewals, labelling and in general Product Life cycle management regulatory applications.

Compliance

• Provide internal stakeholders with accurate and up-to-date information on the regulatory status of assigned products.
• Ensure proper use of the Artwork Management System to support efficient artwork creation and revision processes.
• Implement and maintain regulatory databases and systems in compliance with local requirements and internal standards.
• Maintain complete, accurate, and up-to-date regulatory files and archives.
• Contribute to the development, implementation, and continuous improvement of SOPs to ensure compliance with applicable regulations.
• Support the implementation of updated regulatory documentation in alignment with agency requirements and internal policies.
• Address regulatory process-related issues, ensuring timely resolution.
• Conduct investigations in accordance with our company standards and local procedures.
• Collaborate closely with local teams on key regulatory activities, including Quality Notifications, GMP inspections, vaccine release documentation, and Annual Product Reviews.

Labeling and Artwork

• Ensure the timely availability of packaging materials, including package leaflets and other artwork, in compliance with Artwork Management procedures and established timelines.

Cross-Functional Activities

• Coordinate timely and appropriate actions related to deletions, divestitures, and acquisitions.
• Participate in subsidiary product and launch teams, providing regulatory guidance.

Regulatory Policy & Environment

• Monitor and evaluate new and emerging regulations, as well as proposed changes, assessing their potential impact on business and operations.
• As required, Represent the company in task forces organized by the pharmaceutical industry and regulatory agencies, contributing to policy discussions and regulatory strategy.

Qualifications, Skills & Experience

• Degree in Pharmacy, Life Sciences, or a related field, or equivalent qualification.
• Minimum of 8 years of experience in a Registration Department or equivalent role, including interactions with COFEPRIS .
• Strong knowledge of local legislation, procedures, and guidelines governing pharmaceutical products.
• Excellent verbal and written communication skills.
• Strong organizational and planning abilities.
• Experience in Oncology is required, Biological, Biotechnological, small molecules, etc.
• High attention to detail, adaptability, and the ability to manage multiple priorities under tight deadlines.
• Disciplined, proactive, and able to coordinate tasks effectively across teams.
• Ability to navigate complex regulatory environments with diplomacy and assertiveness when engaging with internal and external stakeholders.
• Proficiency in English.
• Client-oriented mindset aligned with our company´s leadership vision.
• Focus on results, strategic planning, accountability, and execution excellence.

Required Skills

• Adaptability
• Audits Compliance
• Detail-Oriented
• Drug Regulatory Affairs
• Employee Training Programs
• Global Communications
• Pharmaceutical Regulatory Affairs
• Pharmacovigilance
• Process Improvements
• Projec