CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC
Development and implementation of regulatory strategies, processes and timelines for grant of ANDAs.
Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
Demonstrate subject matter and area expertise.
Collaborate with internal and external clients,
Supporting and enabling effective and efficient communication that results in operational excellence.
Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
Education & Experience
Master’s degree in Pharma
Previous experience that provides the knowledge, skills,
and abilities to perform the job (comparable to 4 to 6 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities
Excellent technical data interpretation skills
Excellent interpersonal skills including problem solving
Excellent oral and written communication skills with strong presentation skills
Significant knowledge of US Regulations
Excellent computer skills; Positive knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
Ability and desire to work in a team-oriented environment.
Excellent written and verbal communication skills
Highly proficient with Microsoft Word, PowerPoint and Excel.
Possesses a collaborative, results-driven style.
Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Other requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones