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.
- Chance 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 : (phone hidden)

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

Perks

- Flexible schedule
- Food provided
- Provident Fund

Work Location: In person

📌 Regulatory Affairs – Executive / Trainee (Tharamani)
🏢 Axxelent Pharma and Science Private
📍 Tharamani