We are looking for a highly skilled and experienced Assistant Manager to join our team in the Regulatory Affairs department. The ideal candidate will have 2-5 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
Roles and Responsibility
- Compile and submit USDMF and EUDMF documents to regulatory authorities.
- Compile amendments and annual reports for filed DMF?s.
- Respond to queries from regulatory authorities.
- Ensure compliance with regulatory requirements and guidelines.
- Collaborate with cross-functional teams to meet regulatory deadlines.
- Maintain accurate and up-to-date records of regulatory submissions and responses.
Job Requirements
- Minimum 2 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
- Solid knowledge of regulatory requirements and guidelines.
- Excellent communication and collaboration skills.
- Ability to work under pressure and meet deadlines.
- Strong analytical and problem-solving skills.
- Bachelor's degree in any discipline; relevant postgraduate degrees are an added advantage.
About Company
Hetero Drugs Limited is a leading pharmaceutical company committed to delivering high-quality products and services to its customers.
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