Experience
Up to 3 yrs
Salary (CTC)
₹4.4L - ₹5L
Job Location
Gurugram, India
Vacancy
1
Designation
Regulatory Affairs Associate
Job Type
Not specified
Job Description
- Review and analyze technical documentation for regulatory filings to ensure compliance with US regulations.
- Conduct gap analysis and remediation for module 3 -CMC to identify areas for improvement.
- Develop and implement regulatory strategies, processes, and timelines for ANDA grants.
- Prepare and compile new ANDAs, amendments, supplements, annual reports, 505(b)(2) and 505(b)(1) filings.
- Collaborate with internal and external clients to ensure effective communication and operational excellence.
- Demonstrate subject matter expertise in country regulations and regulatory guidelines.
Job Requirements
- Master's degree in Pharma or equivalent.
- Previous experience in regulatory affairs, preferably in CMC review of technical documentation.
- Excellent technical data interpretation skills and interpersonal skills, including problem-solving abilities.
- Strong oral and written communication skills with presentation abilities.
- Significant knowledge of US Regulations and excellent computer skills, including document management systems.
- Ability to work in a team-oriented environment and possess a collaborative, results-driven style.
- Flexible and adaptive, with the ability to work under pressure and provide quality outputs within tight timelines.
- Proficient with Microsoft Word, PowerPoint, and Excel.
Additional Info
The incumbent may be required to work in shifts catering to different time zones as needed.
No Referrers Available
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