Regulatory Affairs Specialist (Temporary)

MSD Malaysia; Bogotá; Híbrido; COP 90.000.000 - 150.000.000; Jornada completa

Descripción de la vacante

Merck & Co., Inc. seeks a Regulatory Affairs professional in Bogotá to execute the regulatory road map for the assigned portfolio and support HQ, marketing, logistics, and quality teams.

You will interact with the regulatory agency, manage filings, and oversee promotional material review for compliance. The role requires a bachelor’s degree in pharmaceutical sciences, English fluency, and 2+ years of pharma regulatory experience.

Formación

• Bachelor's degree in Pharmacist / Pharmaceutical sciences required.
• Fluency in English – speaking, writing, reading- highly recommendable.
• More than 2 years in pharmaceutical industries in Regulatory affairs positions.
• Knowledge of local regulations general and specific for drugs, small molecules, and biologics.
• Ability to communicate effectively, both verbally and in writing, with individuals at all levels of the organization.

Responsabilidades

• Be updated on new or changes in laws, regulations, normative, in force or under proposal to keep the company aware and in compliance.
• Ensure and execute regulatory strategy and compliance for preparation, submission and monitoring of the regulatory procedures such as: New Registrations (OMA), New indications, Renewals, Variations (PAC), and other regulatory procedures in general, etc.
• Evaluate, review, and timely present to the regulatory agency the materials used from Oncology, Pharma, Vaccines, and Access business units in promotional and non-promotional activities as required, ensuring compliance with current regulations.
• Support Tenders and Sales obtaining the necessary documentation for their processes.
• Establish good working relationships with internal and external staff maintaining a professional image on behalf of the company.
• Execute labeling updates of the products within established due dates and plan filings in compliance with HQ and regulatory agency requirements.

Conocimientos

Regulatory strategy

eCTD

Regulatory submissions

Regulatory compliance

Regulatory communications

Technical writing

Regulatory reporting

Regulatory affairs management

Adaptability

Detail-oriented

Educación

Bachelor's degree in Pharmacist / Pharmaceutical sciences

Descripción del empleo

Job Summary

Job Description Execute the Regulatory Road Map of the products in the assigned portfolio and at a transversal level as required by the area. Ensure compliance with local regulations to achieve the regulatory objectives for the subsidiary. Provide advisory and support to HQ stakeholders, marketing, logistics, quality, planning divisions, among others, in the projects that are required. Interact with the agency, follow up on regulatory filings and procedures related with the portfolio and projects assigned as required. Also, this role is responsible for leading the evaluation and notification of Promotional and Non-Promotional Materials of the company, as required, to the regulatory agency.

Main Functions

• Be updated on new or changes in laws, regulations, normative, in force or under proposal to keep the company aware and in compliance with the different government regulations.
• Ensure and execute regulatory strategy and compliance for preparation, submission and monitoring of the regulatory procedures such as: New Registrations (OMA), New indications, Renewals, Variations (PAC), and other regulatory procedures in general, etc. for the assigned Portfolio and at a transversal level as required.
• Evaluate, review, and timely present to the regulatory agency the materials used from Oncology, Pharma, Vaccines, and Access business units in promotional and non-promotional activities as required. Ensuring compliance with current regulations and providing cross‑functional support in the impacted processes.
• Support Tenders and Sales (and other areas that may require it) obtaining the necessary documentation for their processes (eg: Letters, GPM, Certifications, among others).
• Establish good working relationships with both internal and external staff (regulatory agency, associations, regulatory consultants) maintaining a professional image on behalf of the company.
• Execute labeling updates (information to prescribe and insert) of the products within the established due dates. Planning filing and implementation in compliance with what is approved or required by HQ and the regulatory agency.
• Protect the company's information by ensuring that it is not disclosed except when necessary and when it is duly covered with the appropriate confidentiality agreements.
• Execute Regulatory Road Map for portfolio assigned. Provide revision to local RA SOPs updates and comply with the established there.
• Maintain updated the certificates of Good Manufacturing Practices of all the corresponding sites and Certificates of Pharmaceutical Products for portfolio assigned.
• Perform trainings as required within the established times.
• Perform champion/SME tasks of the assigned process or internal system.
• Keep updated the different corporate regulatory tracking, repository, or archive tools, etc. within the established times, maintaining KPIs with required standard.
• Request artworks updates when apply through the corporate system, ensuring right first time within the established times.
• Participation and/or collaborative in trade associations.

Qualifications

Bachelor’s degree in Pharmacist / Pharmaceutical sciences required.

Fluency in English - speaking, writing, reading- highly recommendable.

Experience

More than 2 years in pharmaceutical industries in Regulatory affairs positions.

Prior experience in the pharmaceutical industry is preferred.

Prove knowledge in local regulations general and specific for drugs, small molecules, and biologics.

Ability to communicate effectively, both verbally and in writing, with individuals at all levels of the organization.

Management internal platforms/programs for regulatory activities.

Good organizational skills with the ability to effectively manage multiple activities across various projects simultaneously.

Required Skills

• Adaptability
• Detail‑Oriented
• Electronic Common Technical Document (eCTD)
• Employee Training Programs
• Pharmaceutical Regulatory Affairs
• Pharmacovigilance
• Regulatory Affairs Compliance
• Regulatory Affairs Management
• Regulatory Communications
• Regulatory Compliance
• Regulatory Experience
• Regulatory Reporting
• Regulatory Strategy Development
• Regulatory Submissions
• Technical Writing

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.

Employee Status: Project Temps (Fixed Term) Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 09/25/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.