Asst. Manager
4 days ago
Job Title :- Assistant Manager
Reports To:- Senior Manager
Job Description::
• CMC review of technical documentation for regulatory filings to various markets – market:
EU & UK- Gap Analysis and Remediation for module 3 -CMC
• Development and implementation of regulatory strategies, processes and timelines for grant
of MAs.
• Prepare and compile new CTD dossiers, renewals and variations 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
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development
guidelines
• 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.
• Demonstrates ability to evaluate information and data with a defined, studied process and
report results in a thoughtful, organized manner
• 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
Location::
Gurgaon, Haryana (INDIA)
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