Regulatory Affairs – Executive / Trainee

About Us

Axxelent Pharma Science Private Limited is a research-driven pharmaceutical organization committed to delivering innovative, high-quality, and regulatory-compliant solutions for the global healthcare industry.

We are looking for enthusiastic and talented M.Pharm freshers to join our Regulatory Affairs team and build a career in global pharmaceutical regulatory submissions and compliance.

Position Summary

We are seeking a motivated M.Pharm Fresher – Regulatory Affairs to support regulatory activities related to pharmaceutical products, regulatory submissions, documentation, and compliance.

The candidate will work closely with Regulatory Affairs, Quality Assurance, Analytical R&D, Formulation R&D, and other cross-functional teams to support preparation, compilation, review, and maintenance of regulatory documentation.

This is an excellent opportunity for an M.Pharm fresher interested in developing a career in Global Regulatory Affairs and Pharmaceutical Regulatory Submissions.

Key Responsibilities

• Support preparation and compilation of regulatory submission documents.
• Assist in preparation, formatting, and review of regulatory documents and technical dossiers.
• Support compilation of documents for CTD / eCTD submissions.
• Assist in preparation and maintenance of regulatory submission packages.
• Coordinate with internal departments to collect required technical and supporting documents.
• Support regulatory document tracking and submission status updates.
• Assist in reviewing documents for completeness, consistency, and compliance with regulatory requirements.
• Maintain regulatory databases, trackers, and submission records.
• Support preparation of responses to regulatory authority queries under the guidance of senior team members.
• Assist in preparation and maintenance of product registration documents.
• Support activities related to regulatory variations, amendments, renewals, and post-approval changes.
• Conduct basic regulatory research and track applicable regulatory guidelines and requirements.
• Support preparation of regulatory correspondence and other regulatory documentation.
• Ensure proper document control, version management, and traceability of regulatory documents.
• Coordinate with cross-functional teams to ensure timely completion of regulatory activities.
• Maintain confidentiality and ensure compliance with company procedures and applicable regulatory requirements.

Required Qualification

M.Pharm – Master of Pharmacy

Only M.Pharm candidates are eligible.

Experience

• Freshers are encouraged to apply.
• 0–1 year of experience in Regulatory Affairs, Regulatory Submissions, or Pharmaceutical R&D may also be considered.

Preferred Knowledge

• Basic understanding of Pharmaceutical Regulatory Affairs.
• Basic knowledge of CTD / eCTD structure.
• Understanding of pharmaceutical product development and regulatory documentation.
• Basic knowledge of ICH guidelines.
• Awareness of regulatory requirements for pharmaceutical products.
• Basic understanding of USFDA, EMA, MHRA, WHO, and other global regulatory agencies is an advantage.
• Basic knowledge of GMP and pharmaceutical quality systems.
• Good understanding of pharmaceutical terminology.

Preferred Skills

• Strong written and verbal communication skills.
• Good documentation and technical writing skills.
• Excellent attention to detail.
• Good analytical and organizational abilities.
• Ability to learn regulatory requirements quickly.
• Good MS Office skills, particularly Word and Excel.
• Ability to coordinate effectively with cross-functional teams.
• Ability to work independently as well as in a team.
• Strong interest in building a career in Regulatory Affairs.

Career Opportunity

The selected candidate will have the opportunity to develop expertise in:

• Global Regulatory Affairs
• Regulatory Submissions
• CTD / eCTD Documentation
• Regulatory Documentation
• Product Registration
• Regulatory Variations
• Regulatory Authority Correspondence
• Global Regulatory Guidelines
• Pharmaceutical Compliance

Why Join Axxelent Pharma Science?

• Opportunity to start a career in Global Pharmaceutical Regulatory Affairs.
• Exposure to regulatory submissions and international regulatory requirements.
• Opportunity to work with experienced pharmaceutical professionals.
• Collaborative and research-focused work environment.
• Structured learning and professional development opportunities.
• Career growth opportunities in Regulatory Affairs.

Salary

Best in Industry
Commensurate with qualifications and company standards.

Application Process

Interested M.Pharm freshers can share their updated resume to:

[email protected]
[email protected]

Phone number : 9500593997

Pay: ₹240,000.00 - ₹260,000.00 per year

Benefits:

• Flexible schedule
• Food provided
• Provident Fund

Work Location: In person