Review technical documentation for regulatory filings to various markets, including US.
Conduct gap analysis and remediation for module 3 - CMC.
Develop and implement regulatory strategies, processes, and timelines for ANDAs.
Prepare and compile new ANDAs, amendments, supplements, annual reports, 505(b)(2), and 505(b)(1) filings ensuring conformance with applicable regulatory guidelines.
Critically review documentation intended for submission to agencies for internal consistency and adherence to relevant guidelines.
Collaborate with internal and external clients to ensure effective communication and operational excellence.

Job Requirements

Master's degree in Pharma or equivalent.
Previous experience providing knowledge, skills, and abilities to perform the job, or an equivalent combination of education, training, and experience.
Excellent technical data interpretation, interpersonal, and problem-solving skills.
Strong oral and written communication skills with presentation abilities.
Significant knowledge of US Regulations and excellent computer skills, including document management systems and Microsoft Word, PowerPoint, and Excel.
Ability and desire to work in a team-oriented environment with flexibility and adaptability under pressure.
Proficient with Microsoft Word, PowerPoint, and Excel.
Flexible, adaptive, and able to work under pressure and provide quality outputs within tight timelines.
As required, the incumbent may be required to work shifts catering to different time zones.

Associate/Associate Regulatory Affairs US

Job Description