Regulatory Strategy & Submissions Lead

MSD LATAM; Bogotá ciudad; Híbrido; COP 90.000.000 - 180.000.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Descripción de la vacante

Merck & Co., Inc. in Colombia seeks a Regulatory Affairs professional to execute the Regulatory Road Map for the assigned portfolio, ensure local regulatory compliance, and provide advisory support to HQ stakeholders, marketing, logistics, and quality teams.

You will interact with the regulatory agency, lead filings for registrations, variations, and renewals, and supervise labeling updates and documentation across projects. Hybrid work arrangements are offered.

Formación

• Bachelor’s degree in Pharmacist / Pharmaceutical sciences required.
• Fluency in English - speaking, writing, reading - highly recommendable.
• More than 2 years in pharmaceutical regulatory affairs.

Responsabilidades

• Execute the Regulatory Road Map for the portfolio assigned.
• Ensure compliance with local regulations to achieve regulatory objectives.
• Interact with the regulatory agency and follow up on filings and procedures.
• Lead evaluation and notification of promotional and non-promotional materials.
• Provide advisory support to HQ stakeholders, marketing, logistics, quality, and planning.
• Coordinate labeling updates and plan filings in line with HQ requirements.
• Maintain regulatory documentation and participate in trade associations.

Conocimientos

Adaptability

Detail-Oriented

eCTD

Pharmaceutical Regulatory Affairs

Pharmacovigilance

Regulatory Compliance

Regulatory Submissions

Technical Writing

Educación

Bachelor’s degree in Pharmacist / Pharmaceutical sciences

Descripción del empleo

Merck & Co., Inc. in Colombia seeks a Regulatory Affairs professional to execute the Regulatory Road Map for the assigned portfolio, ensure local regulatory compliance, and provide advisory support to HQ stakeholders, marketing, logistics, and quality teams.

You will interact with the regulatory agency, lead filings for registrations, variations, and renewals, and supervise labeling updates and documentation across projects. Hybrid work arrangements are offered.