Associate - Regulatory Affairs

6 months ago

Gurugram Haryana, India DDReg Pharma Full time

-Full Time
Gurgaon
Posted 5 days ago

Job title Associate - Regulatory Affairs
- Reports to Senior Associate/Astt Manager/Manager - Regulatory Affairs
- **Job purpose**:
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

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)
- 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
- **Education & Experience**:

- Master’s degree in Pharma discipline with 2 years experience

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- 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
- **Direct reports**:
0 to start with
- **Location**:
1. Gurgaon
- 2. Mumbai

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