Regulatory Affairs Specialist

1 day ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 18,00,000

Regulatory affairs specialists play a vital role in ensuring compliance with regulatory requirements and facilitating the smooth operation of businesses.

This position requires an individual with expertise in regulatory affairs, including experience with eCTD software and e-publishing requirements throughout the project lifecycle. The ideal candidate will have hands-on experience with initial MAA submission & Variations for EU, as well as strong technical knowledge, review skills and understanding of regulatory submissions.

Responsibilities:
  • The compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU, UK and AUS-NZ in eCTD format and submission to respective Regulatory Agencies.
  • Compilation and submission of variation applications for EU, UK and AUS-NZ.
  • Review of documents related to compilation of dossiers and query responses.
  • Up-to-date knowledge of regulatory guidelines and requirements.
Requirements:
  • Hands-on experience with eCTD software and e-publishing requirements throughout the project lifecycle.
  • Experience handling initial MAA submission & Variations for EU.
  • Strong technical knowledge, review skills and understanding of regulatory submissions.
  • Knowledge of CTD /eCTD requirements for modules 2 and 3 is mandatory.
  • Hands-on experience with compilation of module 1 and portal submissions would be preferable.
  • Ability to try new approaches when faced with challenges.
  • Good analytical and learning attitude.
  • Excellent communication (written and oral) and inter-personal skills.
Benefits:

This role offers a unique opportunity for individuals to develop their skills and expertise in regulatory affairs, working closely with cross-functional teams to achieve business objectives.

What We Offer:
  • A dynamic and supportive work environment.
  • Ongoing training and development opportunities.
  • Competitive compensation package.

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