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Manager – Regulatory Affairs – EM

7 - 10 years

0 Lacs

Gurgaon Haryana India

Posted:1 week ago| Platform: Linkedin logo

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Skills Required

documentation analysis remediation development strategies gcc controls consistency communication regulations combination training data interpretation presentation management excel word powerpoint collaborative zones qos software developer stack mongodb express.js react.js node.js

Work Mode

On-site

Job Type

Full Time

Job Description

  • CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC
  • Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN.
  • Review of CTD dossiers , variations, change controls, renewals and 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
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 to 10 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills And Abilities

  • Excellent technical data interpretation skills
  • Excellent interpersonal skills including problem solving
  • Excellent oral and written communication skills with strong presentation skills
  • Significant knowledge of US Regulations
  • 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.
  • 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)Related
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