Novumgen is inviting applications for the position of Executive – Regulatory & Scientific Affairs (Formulations) at its Vadodara location. This opportunity is suitable for pharmaceutical regulatory affairs professionals with 2–4 years of experience who have hands-on knowledge of CMC documentation, CTD/eCTD dossier preparation, lifecycle management, and regulatory submissions for the UK and European markets.

Candidates with B.Pharm, M.Pharm, B.Sc or M.Sc qualifications and relevant regulatory affairs experience can consider this opening. The role offers exposure to international regulatory submissions and compliance requirements involving EMA and MHRA guidelines.

Novumgen Job Vacancy – Overview

About the Role

The Executive – Regulatory & Scientific Affairs will support regulatory activities for pharmaceutical formulation products intended for European and UK markets.

The selected candidate will work on CMC documentation, CTD/eCTD dossiers, regulatory submissions, variations, renewals, post-approval activities and responses to health authority queries while ensuring compliance with applicable EMA and MHRA regulatory requirements.

Key Responsibilities

• Prepare and review CMC documentation for Modules 2 and 3 for pharmaceutical formulation products.
• Compile, review and maintain CTD/eCTD dossiers for product registrations.
• Support regulatory variations, renewals and post-approval submissions.
• Assist with regulatory submissions for European and UK markets.
• Prepare and coordinate responses to queries received from health authorities.
• Ensure dossiers comply with applicable EMA, MHRA and other regulatory guidelines.
• Coordinate with regulatory authorities and internal cross-functional teams throughout the product lifecycle.
• Support regulatory lifecycle management activities for pharmaceutical products.
• Identify potential regulatory risks and contribute to timely compliance with changing global requirements.
• Maintain high-quality regulatory documentation and submission records.

Qualifications

Candidates with the following educational backgrounds may be considered:

B.Pharm – Eligible with relevant Regulatory Affairs and CMC experience.

M.Pharm – Particularly relevant for candidates specializing in Pharmaceutics or Regulatory Affairs.

B.Sc / M.Sc in Life Sciences – Candidates should have relevant hands-on regulatory affairs experience aligned with the role.

Applicants should have 2–4 years of relevant experience.

Skills Required

Candidates should have practical knowledge of:

• Regulatory Affairs for pharmaceutical formulations
• CMC documentation
• CTD and eCTD dossier preparation
• Modules 2 and 3 documentation
• Regulatory lifecycle management
• European pharmaceutical regulations
• UK pharmaceutical regulations
• EMA guidelines
• MHRA requirements
• Product registrations and variations
• Renewals and post-approval submissions
• Health Authority query responses
• Regulatory compliance and documentation

Strong analytical, documentation, coordination and communication skills are also important for this position.

Why Consider This Regulatory Affairs Opportunity?

This Novumgen regulatory affairs job provides professionals with an opportunity to gain further exposure to European and UK pharmaceutical markets.

The position involves end-to-end regulatory activities across CMC documentation, dossier compilation, health authority interactions and product lifecycle management. This can be particularly relevant for professionals building careers in international pharmaceutical regulatory affairs and CMC regulatory functions.

Who Should Apply?

This opening is particularly relevant for candidates who:

• Have 2–4 years of Regulatory Affairs experience.
• Have worked on pharmaceutical formulation products.
• Have hands-on experience preparing CMC documentation.
• Understand CTD/eCTD dossier structure and lifecycle management.
• Have exposure to UK or European regulatory submissions.
• Understand EMA and MHRA regulatory requirements.
• Hold B.Pharm, M.Pharm, B.Sc or M.Sc qualifications relevant to the position.

Candidates without relevant hands-on regulatory affairs experience should note that the vacancy specifically requests 2–4 years of experience, so this is not presented as a fresher position.

How to Apply for Novumgen Regulatory Affairs Job

Interested and eligible candidates can send their updated CV/resume directly to the email address provided in the recruitment announcement:

Email: tisha.thakkar@novumgen.com