Executive - RA

22 hours ago

Navi Mumbai, India Lupin Full time

Job Description

  • Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers.
  • Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market.
  • To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required.
  • To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle

Work Experiance

Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years).

Submission of new submissions, deficiency responses and/or post-approval submissions for above markets.

Worked on various dosage forms including complex generics.

Compilation of Module 2 and 3 CTD sections for above submissions. Review of documents for all these sections.

Knowleage of ICH as well as country specific guidance for documents to be submitted in all above sections.

Hands on experiance for ECTD compilation.

Competencies

Strategic Agility

Process Excellence

Collaboration

Innovation & Creativity

Result Orientation

Stakeholder Management

Customer Centricity

Developing Talent

Education

Masters

Graduation in Pharmacy or Science

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