Regulatory Affairs (Formulations) Executive to Manager Hiring Axxelent Pharma

Regulatory Affairs (Formulations) Executive to Manager Hiring Axxelent Pharma

Exciting Career Opportunities in Regulatory Affairs (Formulations) at Axxelent Pharma – Chennai

Are you an experienced professional in Regulatory Affairs (Formulations) looking for your next career move? Axxelent Pharma Science Private Limited, a US FDA & Health Canada-approved pharmaceutical company, is currently hiring for multiple positions ranging from Executive to Manager levels in Regulatory Affairs (Formulations) at their IIT M Research Park, Taramani, Chennai facility.

About Axxelent Pharma

Axxelent Pharma is a leading Contract Development and Manufacturing Organization (CDMO) specializing in formulation R&D and regulatory affairs. The company is dedicated to delivering high-quality pharmaceutical formulations while ensuring regulatory compliance across key global markets, including the US, EU, Canada, and the UK.

Current Job Openings – Regulatory Affairs (Formulations)

Axxelent Pharma is actively recruiting for the following roles:

• Executive
• Senior Executive
• Assistant Manager
• Deputy Manager
• Manager

A total of 12 vacancies are available in the Regulatory Affairs (Formulations) department.

Key Responsibilities

• Dossier Preparation & Submission for US FDA, EMA, Health Canada, and other key regulatory agencies.
• Strong understanding of global regulatory requirements, including ICH guidelines, GMP compliance, and eCTD structure.
• Handling post-approval activities, such as renewals, amendments, and change control management for marketed products.
• Ensuring Regulatory Intelligence & Compliance with evolving regulations in global markets.
• Demonstrating technical and scientific expertise in different dosage forms.
• Coordinating with internal teams and regulatory agencies through effective written and verbal communication.

Eligibility Criteria

Educational Qualifications

Candidates must have a degree in one of the following fields:

• B Pharm / M.Pharm (Pharmaceutical Sciences)
• B.Tech / M.Tech (Pharmaceutical / Biotechnology)

Experience Required

• 2 to 12 years of experience in Regulatory Affairs – Formulations.
• Experience in dossier preparation, regulatory submissions, and compliance is mandatory.

Job Location

• IIT M Research Park, Taramani, Chennai

  

How to Apply?

Interested candidates can send their resumes to: 📧 Email: vrpradeep@axxelent.com, corphr@axxelent.com
📱 WhatsApp: 9789098123

Table: Job Vacancy Overview