Senior Associate– API_RA

5 days ago

Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time

Job Descriptions

  • CMC review of technical documentation for regulatory filings to various markets – market: EU & UK, US- Gap Analysis and Remediation for module 3 -API
  • Prepare and compile Section 322, QOS & QbR ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
  • Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
  • 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 various agencies' website.

Education & Experience

  • Master's degree in Pharma, Msc Chemistry
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years') or equivalent combination of education, training, & experience.

Knowledge, Skills And Abilities

  • Excellent technical data interpretation 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
  • Excellent computer skills; 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

Location
Gurgaon, Haryana (INDIA)

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