Job title Associate – Regulatory Affairs
Reports to Senior Associate/Astt Manager/Manager – Regulatory Affairs
To carry out Regulatory Review and Compilation of Technical documentation & dossiers for
Various Markets in compliance to applicable regulations and guidelines.
Duties and responsibilities:
• Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical
Data Packages, SmPCs, PIs, PILs, Labelling documents, for regulatory filings in emerging
markets, for DDReg clients
• Assist in development of high quality dossier for various markets
• Adequacy Review and Gap Analysis of Technical Documentation for Non-CTD/CTD dossier
• Closure of comments with the cross functional team & review of additional data generated in
response to review comments per country.
• Compilation of Dossier.
• Review of registration dossier (m1-m5) as per country specific regulatory requirements
• Deficiencies response management from various authorities by coordinating stakeholders
for getting documents and compilation and review of response and compile response to
queries from the MOH.
• Updation of the dossier as per the queries responded (inclusive of all countries)
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational
• Demonstrate high level knowledge of country regulations and regulatory guidelines as
updated from time to time on regulatory agency websites
Education & Experience:
• Master’s degree in Pharma discipline
Knowledge, Skills and Abilities
• Excellent technical data interpretation skills
• Strong project management 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
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions,
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; 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
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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