Sr Associate/Team Lead -Adv Mkts (SRA/TL)- Regulatory Affairs – DDREG Pharma – Gurgaon

To Manage Regulatory Review and Compilation for Various Markets in compliance with applicable regulations and guidelines.

Job Description:

Duties & Responsibilities:

• Providing high-quality CMC review of technical documentation for regulatory filings in EU and US markets, for DDReg clients
• Drive the compilation team with the high quality dossier for various regulated markets
• Providing technical consultation and provides substantive advice on strategy, regulations, and industry best practices.
• Demonstrate subject matter and area expertise.
• Effectively manage CMC projects to deliver quality projects in agreed timelines.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Managing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling reviews
• Demonstrate high-level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA, etc.

Knowledge Skills & 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,/li>
• 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

Location: Gurgaon

Qualification: B.Pharma/M.Pharma

Experience: 5 Years of Relevant Experience, CRO/Pharma Experience Preferred

Contact Details:

Source: https://ddreg.in/career/

Mail CV to info@ddrreg.in

HR@ddreg.in