Novumgen is hiring for the position of Regulatory Affairs Executive for the Mexico Market at its Vadodara, Gujarat location. Candidates with 1 to 4 years of hands-on experience in pharmaceutical regulatory affairs are invited to apply for this opportunity.
The role focuses on preparing and coordinating regulatory submissions to COFEPRIS, managing dossier preparations for new product registrations, renewals, and variations, and handling deficiency responses for marketing authorization applications.
About Novumgen
Founded by a group of experienced pharmaceutical professionals, Novumgen is dedicated to developing and producing innovative, high-quality medicines. The company quickly established itself as a natural leader in the UK market before expanding its product licensing and operations globally.
Driven by a strong focus on research and development, Novumgen has successfully introduced multiple new medicines, attracting investment that enabled the establishment of advanced manufacturing facilities and research laboratories. Today, the company is a well-respected global pharmaceutical organization delivering life-changing medicines that contribute safety and value to patients, healthcare institutions, and prescribers worldwide.
For more information, visit the official website: http://www.novumgen.com
Regulatory Affairs Executive Vacancy Details
Novumgen is looking for a dedicated regulatory professional to join its international regulatory team in Vadodara, focusing specifically on the Mexico market.
Position: Regulatory Affairs Executive – Mexico Market
Location: Vadodara, Gujarat
Experience Required: 1–4 Years
Eligibility Criteria and Qualifications
Candidates interested in this opportunity should meet the following professional requirements:
- Professional Experience: 1 to 4 years of relevant experience in pharmaceutical regulatory affairs, particularly with international market submissions.
- Core Competencies: Familiarity with regulatory agency procedures, dossier compilations, and lifecycle management activities.
Key Responsibilities of the Regulatory Affairs Executive
The role involves comprehensive regulatory compliance, dossier management, and agency coordination tasks, including:
- Preparing and coordinating regulatory submissions for pharmaceutical products to COFEPRIS.
- Supporting dossier preparation for new product registrations, renewals, variations, and modifications.
- Providing regulatory support to cross-functional teams.
- Handling deficiency responses for Marketing Authorization Applications.
- Coordinating with partners to ensure the timely availability of required information.
- Ensuring the timely submission of variations and commercial urgency requests to regulatory authorities.
- Maintaining regulatory project trackers and documentation.
- Managing renewals and other regulatory lifecycle activities.
How to Apply for This Vacancy
Interested candidates can apply by submitting their updated resume through the official application channel:
Application Email: tisha.thakkar@novumgen.com
Ensure that your resume clearly details your regulatory background, dossier submission experience, and professional qualifications before applying.
Candidates are advised to confirm recruitment details through the company’s official communication channels before sharing sensitive professional information or documents. Avoid engaging with unverified intermediaries or unauthorized entities.
Frequently Asked Questions
What experience is required for this vacancy?
Candidates should have 1 to 4 years of experience in pharmaceutical regulatory affairs.
Where is the job located?
The position is located in Vadodara, Gujarat.
Which market does this regulatory position focus on?
This role focuses on regulatory submissions and lifecycle activities for the Mexico market (COFEPRIS).
How can candidates apply?
Candidates can email their updated CV to tisha.thakkar@novumgen.com.