Job purpose

To carry out Regulatory Review and Compilation of Technical documentation & dossiers as part of Life Cycle Management of products in compliance to applicable regulations and guidelines.

Education & Experience

• Master’s degree in Pharma discipline.
• 1-3  years of experience in handling Regulatory Affairs function.

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, communications, etc.
• 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.

Other Requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

• • 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 compilation.
  • 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 excellence.
  • Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites.

Location

• • Gurgaon, Sector-49