DELIVER BETTER DATA TO ENSURE FASTER APPROVAL
Associate/Sr. Associate – Regulatory Affairs (ROW)
Posted 10 months ago
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.
- 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.
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.