Regulatory Lead - Maternity Cover (7 months)

Opella.; Ciudad de México; On-site; MXN 900,000 - 1,300,000; Full time

Job summary

Opella seeks a Regulatory Lead for a 7-month maternity cover in CDMX. You will design regulatory strategies, manage lifecycle activities, and ensure compliance with COFEPRIS while collaborating with Brand & Innovation and external stakeholders to secure timely health authorizations.

The role requires 3–5 years in science/ pharma regulatory areas and leadership experience, with a focus on risk-based decision making and cross-functional teamwork to support product life cycle and advertising

Qualifications

• Education: Bachelor’s degree in Chemical-Biological Sciences (with degree awarded) or related fields.
• Minimum 3-5 years in Science Affairs/pharmaceutical experience (Medical, Regulatory, R&D or similar), including leadership roles.
• Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Development, Clinical Research, or research in health-related areas.

Responsibilities

• Design regulatory strategy for products under responsibility and ensure execution with Regulatory Platform/Center of Expertise.
• Review and define strategy for global/local assessments for new products or projects.
• Lifecycle management of products (renewals, modifications, IPP updates, etc.).
• Provide regulatory input in Brand & Innovation events (workshops, trainings, briefs).
• Ensure submissions to COFEPRIS comply with current requirements.
• Review advertising strategies to ensure regulatory compliance and timely authorizations.
• Communicate potential risks of advertising materials when applicable.
• Maintain global systems related to regulatory impacts of products.
• Build collaboration networks with internal/external stakeholders (chambers, health authority).
• Follow HSE policies and participate in road safety campaigns and investigations.

Education

Bachelor’s degree in Chemical-Biological Sciences

Master’s degree desirable

Job description

Opella seeks a Regulatory Lead for a 7-month maternity cover in CDMX. You will design regulatory strategies, manage lifecycle activities, and ensure compliance with COFEPRIS while collaborating with Brand & Innovation and external stakeholders to secure timely health authorizations.

The role requires 3–5 years in science/ pharma regulatory areas and leadership experience, with a focus on risk-based decision making and cross-functional teamwork to support product life cycle and advertising