Job Description:
- 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 MA- Africas, GCC, LATAM, ASEAN.
- Review of CTD dossiers , variations, change controls, renewals and 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 7 to 10 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; Good 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
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