Regulatory Affairs Executive

Intas Pharmaceuticals; Ahmedabad District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Intas Pharmaceuticals is seeking a Regulatory Affairs professional to support registration and lifecycle management of recombinant products across global markets. You will prepare IND, IMPD, CTD dossiers and briefing books, and maintain regulatory documentation with cross-functional teams.

Responsibilities include updating Administrative, CMC, and Clinical dossiers, responding to agency queries, tracking registrations, developing variation packages, and monitoring global guideline changes to

Qualifications

• 2–4 years of regulatory affairs experience, preferably with recombinant or biologic products.
• Master's degree in Life Sciences, Pharmacy, Biotechnology, or related field.
• Experience preparing IND/IMPD/CTD submissions and regulatory dossiers.

Responsibilities

• Prepare and compile regulatory submissions (IND, IMPD, CTD) for global product registrations.
• Update dossiers (Administrative, CMC, Clinical) and respond to agency queries.
• Track regulatory registrations and product lifecycle data for global compliance.
• Develop and submit variation packages for lifecycle management of products.
• Monitor changes in regulatory guidelines and approval processes worldwide.
• Conduct regulatory impact assessments for product or process changes.
• Support regulatory audits by customers and MOH.
• Perform gap analysis and review clinical/CMC docs for submissions.

Skills

Global regulations

IND/IMPD/CTD

Documentation

Regulatory submissions

Impact assessment

Independent work

Audits support

Regulatory trends

Education

Master's degree

Job description

Job Summary:

Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems.

Key Responsibilities:

• Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations.


• Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner.


• Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulations.


• Develop and submit variation packages for ongoing lifecycle management of approved products.


• Monitor and interpret changes in regulatory guidelines and approval processes worldwide.


• Conduct regulatory impact assessments for product or process changes.


• Support regulatory audits conducted by customers and Ministry of Health (MOH).


• Perform gap analysis and review clinical and CMC documentation to support regulatory submissions.

Skills & Competencies:

• Strong knowledge of global regulatory requirements and submission formats (FDA, EMA, ICH guidelines).


• Hands-on experience with preparation of IND, IMPD, CTD dossiers and regulatory documentation.


• Detail-oriented with excellent document management skills.


• Effective communication and coordination with cross-functional teams.


• Analytical skills to assess regulatory impacts and address compliance issues.


• Ability to work independently and manage multiple regulatory activities simultaneously.

Proficiency with regulatory submission tools and tracking systems.

Education Qualification:

Master's Degree in Life Sciences, Pharmacy, Biotechnology, or related discipline.

Experience:

• 2 to 4 years of experience in regulatory affairs, ideally with exposure to recombinant or biologic products.