Regulatory Manager

18 hours ago

Hyderabad, Telangana, India Graviti Pharmaceuticals Full time

Job Title: Regulatory Manager – Europe Market

Location:
Hyderabad, India

Experience:
10–12 Years

Industry:
Pharmaceuticals / Healthcare

Employment Type:
Full-time

About the Companys

Graviti Pharmaceuticals
is a
sister concern of the prestigious Yashoda Group of Hospitals, Hyderabad.

Focused on
innovation and development
, Graviti channels a significant share of its revenue into
advanced research
, driving the creation of next-generation therapies and high-impact pharmaceutical solutions. As part of our global expansion, we are now entering the
European market
to deliver high-quality healthcare solutions worldwide.

Role Overview

We are seeking a highly skilled and experienced
Regulatory Manager (Europe Market)
to lead and manage regulatory submissions and post-approval activities for our growing product portfolio. The role requires strong expertise in handling
solid oral and sterile dosage forms
and a deep understanding of
European regulatory guidelines.

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.

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