Regulatory Affairs Executive Pharmaceutical Registrations

Why This Role Matters

In the pharmaceutical industry, regulatory compliance is the backbone of product approval and market sustainability. Every medicinal product must meet strict regulatory requirements before it reaches patients. Timely and accurate dossier submissions, effective authority communication, and lifecycle documentation management ensure uninterrupted product availability and protect public health.
The Regulatory Affairs Executive plays a crucial role in managing product registrations, renewals, and post-approval variations. This position directly supports business growth by ensuring products remain compliant with evolving regulatory frameworks. By coordinating across departments and maintaining precise documentation, the role ensures smooth regulatory operations throughout the product lifecycle.

Job Description

We are hiring a Regulatory Affairs Executive responsible for preparing and submitting regulatory dossiers, managing product registrations, and ensuring compliance with applicable national and international guidelines. The role involves coordination with cross-functional teams, responding to regulatory authority queries, and maintaining regulatory documentation systems.
The candidate will be responsible for end-to-end regulatory submission support, including new registrations, renewals, and variations, while ensuring product labeling and packaging compliance. The role requires strong attention to detail, regulatory knowledge, and the ability to manage multiple timelines effectively.

Key Features of the Role

• End-to-end responsibility for dossier preparation and submission
• Exposure to new registrations, renewals, and variations
• Coordination with cross-functional departments
• Direct handling of regulatory authority queries
• Involvement in labeling and artwork compliance review
• Lifecycle documentation and database management

Responsibilities

• Prepare and submit regulatory dossiers for new product registrations
• Manage renewals and post-approval variations in accordance with applicable guidelines
• Ensure compliance with national and international regulatory requirements
• Coordinate with R&D, Quality Assurance, Manufacturing, and Packaging teams to collect required documentation
• Review product labeling, packaging materials, and artworks to ensure regulatory accuracy
• Respond to regulatory authority queries within defined timelines
• Maintain updated regulatory records, licenses, and submission trackers
• Monitor changes in regulatory guidelines and implement necessary updates
• Maintain regulatory databases and ensure proper archival of submission documents
• Support audits and inspections by providing regulatory documentation
• Track submission timelines and ensure timely follow-up with authorities
• Assist in preparing regulatory strategy inputs for new product launches

Required Qualifications

• Strong understanding of regulatory submission processes
• Knowledge of dossier formats and regulatory documentation requirements
• Familiarity with labeling compliance and packaging review
• Good knowledge of pharmaceutical regulatory guidelines
• Strong documentation management and organizational skills
• Ability to work within defined regulatory timelines

Educational Requirements

• Bachelor’s degree in Pharmacy (B.Pharm)
• Master’s degree in Pharmacy (M.Pharm) preferred
Equivalent qualifications in Pharmaceutical Sciences or Life Sciences may also be considered.

Experience and Skills

• 2–5 years of experience in Regulatory Affairs within the pharmaceutical industry
• Experience in preparing and submitting dossiers for registrations, renewals, and variations
• Familiarity with regulatory guidelines applicable to domestic and/or export markets
• Strong written and verbal communication skills
• Ability to coordinate with cross-functional teams effectively
• Detail-oriented approach with strong analytical skills
• Ability to manage multiple projects and meet strict deadlines
• Proficiency in documentation tools and regulatory databases

Salary Insights

Annual salary range: ₹3,21,000 – ₹4,50,000 per year
Compensation is aligned with industry standards for mid-level regulatory professionals in Pune, Maharashtra. Salary may vary depending on experience level, technical expertise, and exposure to regulatory submissions.

Additional Benefits:
• Health Insurance

Company Overview

The organization operates within the pharmaceutical sector and focuses on regulatory compliance, product registration, and lifecycle management. The company is committed to maintaining high standards of regulatory integrity and ensuring that all products meet applicable guidelines before reaching the market.
The work environment promotes cross-functional collaboration, professional development, and continuous regulatory learning to stay aligned with evolving compliance frameworks.

FAQs

1. Is prior regulatory experience mandatory?
Yes, experience in dossier preparation and regulatory submissions is required for this role.

2. Does this role involve authority interaction?
Yes, responding to regulatory authority queries within defined timelines is a key responsibility.

3. Is labeling review part of the job?
Yes, reviewing labeling, packaging, and artwork for regulatory compliance is included in the role.

4. Is this role limited to domestic submissions?
The scope may include domestic as well as export market submissions depending on company requirements.

Application Tips

• Highlight specific dossiers prepared (new registrations, renewals, variations)
• Mention markets handled (India, ROW, etc.)
• Emphasize experience in responding to authority queries
• Showcase labeling and artwork review expertise
• Quantify the number of submissions managed or approvals received
• Demonstrate cross-functional coordination experience