GSK is hiring a Regulatory Affairs Specialist (Job ID: 439408) in Mexico City at Torre Mitikah. This full-time role offers 2–4 years experienced professionals an excellent opportunity to work with COFEPRIS submissions and lifecycle management for vaccines and medicines. Apply before May 9, 2026 for this pharma regulatory affairs job in Mexico.
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About the Company
GSK (GlaxoSmithKline) is a global biopharmaceutical leader with a purpose to unite science, technology, and talent to get ahead of disease together. The company aims to positively impact the health of 2.5 billion people by the end of the decade through innovative vaccines and specialty medicines.
With a strong focus on respiratory, immunology, oncology, HIV, and infectious diseases, GSK maintains high standards of regulatory compliance, patient safety, and operational excellence across global markets, including Mexico.
Job Details
- Company Name: GSK
- Experience: 2 to 4 Years (handling submissions, cancellations, renewals, new molecules)
- Qualification: Bachelor’s degree in Pharmaceutical and Biological Chemistry, Biotechnology Engineering, Chemical Engineering, or related fields
- Location: Mexico City, Torre Mitikah
- Work Type: Full time, On-site
Job Description
GSK is recruiting a Regulatory Affairs Specialist to support the preparation, submission, and maintenance of marketing authorization dossiers for GSK products in Mexico. The role ensures full compliance with local COFEPRIS regulations and company standards while contributing to timely approvals and effective product lifecycle management.
This position involves close collaboration with the Regulatory Affairs Manager, cross-functional teams, and stakeholders to execute regulatory strategies and mitigate risks.
Regulatory Affairs Specialist
- Department: Regulatory Affairs
- Market: Pharmaceutical / Biopharmaceutical
- Role: Regulatory Affairs Specialist
- Experience: 2–4 Years
- Education/Qualification: Bachelor’s degree in Pharmaceutical and Biological Chemistry, Biotechnology Engineering, Chemical Engineering, or related fields
Skills/Qualifications
- Bachelor’s degree in Pharmaceutical and Biological Chemistry, Biotechnology Engineering, Chemical Engineering, or related discipline
- 2–4 years of experience in regulatory submissions (cancellations, renewals, new molecules)
- Advanced English proficiency (spoken and written)
- Solid knowledge of international regulations and Mexican regulatory requirements (COFEPRIS)
- Strong organizational, communication, and cross-functional coordination skills
- Ability to interpret regulatory guidance and implement SOPs
- Preferred: Experience with VEEVA and PowerBI
Key Responsibilities
- Prepare, compile, and submit regulatory dossiers, variations, renewals, and responses to COFEPRIS
- Coordinate cross-functional inputs from CMC, clinical, pharmacovigilance, quality, and supply teams
- Maintain registration files, regulatory databases, and track submission timelines
- Provide regulatory advice and input to lifecycle strategies and project plans
- Identify and escalate regulatory risks with mitigation plans
- Support labelling and packaging reviews
- Contribute to continuous improvement in regulatory processes
- Support competitive intelligence and communicate regulatory landscape insights
Benefits/Perks
- Competitive salary and comprehensive benefits package
- Opportunities for training and career development in regulatory affairs
- Exposure to global regulatory systems and cross-functional collaboration
- Supportive team environment focused on patient impact
- Professional growth aligned with GSK’s mission to get ahead of disease together
How to Apply
Interested candidates can apply directly for Job ID 439408 through the official GSK careers website before the end date of May 9, 2026.
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Verification: To confirm the legitimacy of this posting, you can view the original announcement on the GSK Career page.
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Apply now and contribute to GSK’s mission of advancing patient health through regulatory excellence!
Why You Should Join
GSK offers a purpose-driven culture where regulatory professionals play a critical role in bringing innovative medicines and vaccines to patients. You will gain valuable experience in a dynamic, collaborative environment while working on high-impact projects that align with GSK’s ambition to positively impact billions of lives.
The company emphasizes accountability, innovation, and doing the right thing, providing long-term career stability and development opportunities in the global biopharmaceutical industry.
FAQs
What is the experience required for the GSK Regulatory Affairs Specialist role in Mexico City?
Candidates need 2 to 4 years of experience handling regulatory submissions, including cancellations, renewals, and new molecules.
What qualification is needed for this pharma job?
A Bachelor’s degree in Pharmaceutical and Biological Chemistry, Biotechnology Engineering, Chemical Engineering, or related fields is required.
Is advanced English mandatory for this position?
Yes, advanced English proficiency is a basic qualification for the role.
What is the application deadline for Job ID 439408?
The last date to apply is May 9, 2026.
