Regulatory Strategy Lead - Maternity Cover (CDMX)

Opella; Ciudad de México; On-site; MXN 700,000 - 1,100,000; Full time

Job summary

Opella seeks a Regulatory Lead in CDMX for a 7-month maternity-cover role. You will shape regulatory strategy, ensure compliance, and guide lifecycle management across brands and products.

Collaborate with Brand & Innovation, Commercial, and external authorities to secure timely approvals and maintain high regulatory standards. Ideal candidates have 3–5 years of pharmaceutical regulatory experience, leadership capability, and a degree in Chemical-Biological Sciences (Master’s preferred).

Qualifications

• 3–5 years in science/ pharma regulatory roles with leadership exposure.

Responsibilities

• Design regulatory strategy for products under your responsibility and execute it with cross-functional teams.
• Review global/local assessments for new products or projects.
• Oversee lifecycle management including renewals, modifications and updates.
• Support brand/innovation events with regulatory input and brief development.
• Ensure COFEPRIS submissions meet current requirements.
• Review advertising strategies for regulatory compliance and timely authorizations.
• Identify and communicate potential regulatory risks in materials.
• Maintain regulatory systems and monitor global regulatory impacts.
• Build networks with internal/external stakeholders and uphold ethics.

Skills

Regulatory affairs

Quality

Manufacturing

Pharmacovigilance

Leadership

Education

Bachelor’s degree in Chemical-Biological Sciences

Master’s degree desirable

Job description

Opella seeks a Regulatory Lead in CDMX for a 7-month maternity-cover role. You will shape regulatory strategy, ensure compliance, and guide lifecycle management across brands and products.

Collaborate with Brand & Innovation, Commercial, and external authorities to secure timely approvals and maintain high regulatory standards. Ideal candidates have 3–5 years of pharmaceutical regulatory experience, leadership capability, and a degree in Chemical-Biological Sciences (Master’s preferred).