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

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