Regulatory Manager

Job Title: Regulatory Manager – Europe Market

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About the Companys

Graviti Pharmaceuticals

innovation and development

Role Overview

Regulatory Manager (Europe Market)

Key Responsibilities

• Evaluate and implement regulatory submission strategies for the

  Europe market.

• Prepare, review, and submit

  dossiers (CTD/eCTD)

  in line with EMA and EU regulatory requirements.
• Handle

  post-approval regulatory activities

  , including variations, renewals, and lifecycle management.
• Coordinate with cross-functional teams —

  R&D, QA/QC, Production, and Supply Chain

  — to ensure compliance and timely submissions.
• Stay updated with evolving

  EU/EMA regulations

  and ensure company processes remain aligned.

• Coach and develop

  team members to strengthen their regulatory expertise and submission proficiency.

Key Requirements

• 10–12 years of experience in

  pharmaceutical regulatory affairs

  , focusing on

  European market submissions.

• Proven experience in managing

  solid oral and/or sterile dosage forms.

• Strong knowledge of

  EMA guidelines

  ,

  Module 1 regional requirements

  , and

  eCTD submission systems.

• Excellent communication, planning, and leadership skills.
• Ability to collaborate effectively with cross-functional teams and regulatory authorities.

Educational Qualification

• Master’s degree in

  Pharmacy, Life Sciences, or a related discipline.

Why Join Us

• Be part of a

  rapidly growing pharmaceutical company.

• Work in an

  innovation-driven environment

  contributing to global healthcare advancements.
• Opportunity to

  lead regulatory operations for the European market

  and shape our international growth journey.