Axxelent Pharma, a leading US FDA & Health Canada-approved pharmaceutical company, is hiring for multiple positions in Regulatory Affairs (Formulations) at their IIT M Research Park, Taramani, Chennai facility. If you are an experienced professional in Regulatory Affairs, this is your chance to join a dynamic team and advance your career in the pharmaceutical industry.
About Axxelent Pharma
Axxelent Pharma is a renowned Contract Development and Manufacturing Organization (CDMO) specializing in formulation R&D and regulatory affairs. The company is committed to delivering high-quality pharmaceutical formulations while ensuring compliance with global regulatory standards. With a strong presence in key markets like the US, EU, Canada, and the UK, Axxelent Pharma is a trusted name in the pharmaceutical industry.
Current Job Openings – Regulatory Affairs (Formulations)
Axxelent Pharma is hiring 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 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 possess one of the following degrees:
- 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
The position is based at IIT M Research Park, Taramani, Chennai.
How to Apply
Interested candidates can send their resumes to:
