Novumgen is inviting applications for the position of Regulatory Affairs Executive – Mexico Market at its Vadodara, Gujarat location.
The opportunity is suitable for candidates with 1–4 years of experience in pharmaceutical regulatory affairs.
The role involves regulatory submissions to COFEPRIS, dossier preparation, product registrations, renewals, and regulatory lifecycle management.
Interested candidates with relevant regulatory affairs experience can send their updated CV to the recruitment email address provided below.
Company Overview
Novumgen is hiring a Regulatory Affairs Executive to support pharmaceutical regulatory activities for the Mexico market. The position involves coordinating regulatory submissions, maintaining product registration documentation, and working with cross-functional teams and external partners.
Novumgen Regulatory Affairs Executive Job Details
Position Information
- Department: Regulatory Affairs
- Designation: Regulatory Affairs Executive – Mexico Market
- Location: Vadodara, Gujarat
- Experience: 1–4 years
Job Role & Responsibilities
Key Responsibilities
- Prepare and coordinate regulatory submissions for pharmaceutical products to COFEPRIS, Mexico’s regulatory authority.
- Support dossier preparation for new product registrations, renewals, variations, and modifications.
- Provide regulatory support to cross-functional teams.
- Handle deficiency responses for Marketing Authorization Applications.
- Coordinate with partners to ensure the timely availability of required information.
- Ensure timely submission of variations and commercial urgency requests to regulatory authorities.
- Maintain regulatory project trackers and documentation.
- Manage renewals and other regulatory lifecycle activities.
Eligibility & Qualifications
Educational Qualifications
Candidates should have relevant qualifications for pharmaceutical regulatory affairs. The recruitment announcement does not specify a particular degree.
Experience Requirements
- 1–4 years of experience in pharmaceutical regulatory affairs.
- Familiarity with regulatory submissions and dossier preparation is relevant to the role.
- Experience with product registrations, renewals, variations, and regulatory documentation is beneficial.
Required Skills
- Regulatory submission coordination.
- Pharmaceutical dossier preparation and maintenance.
- Knowledge of Marketing Authorization Applications and deficiency responses.
- Regulatory project tracking and documentation management.
- Coordination with cross-functional teams and external partners.
- Ability to manage submission timelines and regulatory lifecycle activities.
Location & Salary
Job Location
Vadodara, Gujarat, India.
Salary Details
The salary package has not been specified in the recruitment announcement. Compensation may depend on the candidate’s qualifications, experience, and the company’s policies.
How to Apply
Interested candidates can share their updated CV through the recruitment email address below.
Email: tisha.thakkar@novumgen.com
Application Instructions
- Prepare an updated CV highlighting relevant pharmaceutical regulatory affairs experience.
- Include experience in regulatory submissions, dossier preparation, product registrations, renewals, and variations, where applicable.
- Send your CV to tisha.thakkar@novumgen.com.
Frequently Asked Questions
1. Which company is hiring for the Regulatory Affairs Executive position?
Novumgen is recruiting for the Regulatory Affairs Executive – Mexico Market position.
2. What is the required experience?
Candidates should have 1–4 years of experience.
3. Where is the job located?
The position is based in Vadodara, Gujarat.
4. What are the main responsibilities?
The role includes COFEPRIS submissions, dossier preparation, registration renewals, variations, deficiency responses, and regulatory documentation management.
5. How can candidates apply?
Candidates can email their updated CV to tisha.thakkar@novumgen.com.
6. Is a specific educational qualification mentioned?
The recruitment announcement does not specify a particular degree. Candidates should have relevant qualifications and experience for the role.
Job Summary
| Category | Details |
|---|---|
| Company | Novumgen |
| Vacancies | Regulatory Affairs Executive – Mexico Market |
| Required Education | Relevant qualification for pharmaceutical regulatory affairs |
| Experience | 1–4 years |
| Location | Vadodara, Gujarat |