Senior Specialist Regulatory Affairs (Oncology)

Job Description

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.

Additional location(s) Compensation Information:

Required Skills:

Adaptability, Audits Compliance, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

• Search Firm Representatives Please Read Carefully
• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

na

Job Posting End Date:

11/13/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.