Oncology Regulatory Affairs Lead — Hybrid (Mexico)

MSD; Ciudad de México; Hybrid; MXN 1,000,000 - 1,800,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

MSD in Mexico City is seeking a Senior Specialist Regulatory Affairs (Oncology) to lead regulatory submissions, lifecycle management, and interactions with COFEPRIS. The role emphasizes strategic regulatory planning and strong collaboration with internal partners.

The ideal candidate will have 8+ years in regulatory affairs, oncology experience, and fluency in English. Hybrid work arrangements and a proactive, detail-oriented mindset are highly valued in this fast-paced environment.

Qualifications

• Degree in Pharmacy, Life Sciences, or related field.
• Minimum of 8 years of experience in a Registration Department or equivalent.
• Experience with COFEPRIS and local regulations.
• Excellent verbal and written communication skills.
• Experience in Oncology is required.
• Strong organizational and planning abilities.
• Ability to manage multiple priorities under tight deadlines.

Responsibilities

• Lead timely submission of New Marketing Authorization (MA) applications.
• Maintain and renew MA authorizations, variations, and post-approval changes.
• Coordinate CMC post-approval changes, labeling and lifecycle management.
• Provide regulatory guidance to cross-functional teams and stakeholders.
• Monitor regulatory requirements and implement SOPs to ensure compliance.
• Support labeling, artwork, and documentation processes for regulatory submissions.
• Collaborate with local teams and regulatory authorities (COFEPRIS).

Skills

Regulatory planning

English proficiency

Cross-functional collaboration

Regulatory strategy

Communication skills

Education

Pharmacy or Life Sciences degree

Job description

MSD in Mexico City is seeking a Senior Specialist Regulatory Affairs (Oncology) to lead regulatory submissions, lifecycle management, and interactions with COFEPRIS. The role emphasizes strategic regulatory planning and strong collaboration with internal partners.

The ideal candidate will have 8+ years in regulatory affairs, oncology experience, and fluency in English. Hybrid work arrangements and a proactive, detail-oriented mindset are highly valued in this fast-paced environment.