Regulatory Affairs Executive (Mexico Market)

Novumgen Limited; Vadodara; Presencial; INR 800.000 - 1.500.000; Jornada completa

Descripción de la vacante

Novumgen Limited is seeking a Regulatory Affairs professional to prepare and coordinate COFEPRIS submissions for the Mexico market. You will support dossiers for registrations, renewals, and variations, and provide regulatory support across cross-functional teams.

Responsibilities include handling deficiency responses, coordinating with partners, and maintaining trackers for lifecycle activities. This role requires 2–7 years in RA with Mexico market exposure.

Formación

• 2 to 7 years of experience in regulatory affairs.
• Experience with the Mexico market and regulatory submissions is required.

Responsabilidades

• Prepare and coordinate regulatory submissions for pharmaceutical products to COFEPRIS.
• Support preparation and compilation of dossiers for new product registrations, renewals, variations/modifications, and other regulatory procedures.
• Provide regulatory support to cross-functional teams.
• Handle deficiency responses of Marketing Authorization Applications.
• Communicate with partners for timely information availability.
• Ensure timely submission of variation and commercial urgency requests to regulatory authorities.
• Maintain project trackers for regulatory activities.
• Manage renewals and lifecycle activities.

Conocimientos

RA experience

Cross-functional teamwork

Regulatory submissions

Descripción del empleo

Role & responsibilities (Maxico Market)

• Prepare and coordinate regulatory submissions for pharmaceutical products to COFEPRIS.
• Support preparation and compilation of dossiers for new product registrations, renewals, variations/modifications, and other applicable regulatory procedures.
• Provide regulatory support to cross-functional teams.
• Handling of deficiency responses of Marketing Authorization Applications
• Communicate with partners for timely information availability
• Ensure timely submission of variation and commercial urgency requests to relevant regulatory authorities
• Maintenance of different project trackers
• Renewals and other applicable lifecycle activities

Preferred candidate profile

• 2 to 7 Years of experience required in RA
• Required experience in Mexico Market.