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Regulatory Compliance Specialist for Pharmaceutical Formulations

2 weeks ago

Aurangabad, Maharashtra, India Harman Finochem Ltd Full time
Job Overview:

We are seeking an experienced Senior Regulatory Affairs Specialist to join our team at Harman Finochem Ltd. In this role, you will be responsible for ensuring regulatory compliance across various markets, including the US, Europe, and ROW countries.

About the Role:

This is a critical position that requires strong knowledge of regulatory guidelines, laws, and regulations in the pharmaceutical industry. As a Senior Regulatory Affairs Specialist, you will work closely with cross-functional teams, including R&D, Business Development, Commercial Manufacturing, and other stakeholders within the organization. Your key responsibilities will include:

- Reviewing and compiling application dossiers for submission to regulatory agencies such as the US-FDA, EMA, Health Canada, and ROW countries;
- Collaborating with R&D scientists to ensure adherence to regulatory guidelines during formulation development;
- Reviewing and approving CMC documents generated by R&D labs and commercial manufacturing facilities;
- Providing regulatory support and coordination for audits;
- Maintaining accurate records of drug products;

Qualifications:

To be successful in this role, you should possess a Master's degree in Pharmacy (Pharmaceutical Chemistry) and have 6-9 years of experience in the OSD Industry with a proven track record of regulatory affairs exposure in the US and European markets. You should also be proficient in communicating effectively with cross-functional teams and adapting to changing regulatory requirements. This role is based in Shendra, Aurangabad, but you may be required to travel occasionally for meetings and training.