Manager

3 weeks ago

Bengaluru, Karnataka, India Naari Pharma Pvt Ltd. Full time

Naari Pharma is a leading global player in the field of women's health focused on hormones. We have comprehensive FDF product portfolio presence in over 50 countries and shift towards high value formulations with an increased footprint in regulated markets.

Who You Are:

You are skilled professional with deep understanding of regulatory frameworks and have a proven track record of managing the entire regulatory life cycle independently. Your ability to manage projects end-to-end makes you a valued contributor in achieving product approvals.

How You Contribute:

  1. Manage end-to-end regulatory submissions for EU and US markets, ensuring timely filing of dossiers, variations, and renewals.
  2. Coordinate with cross-functional teams to gather data, review documentation, and ensure compliance with regulatory requirements.
  3. Handle regulatory queries from EU and US authorities, ensuring prompt and effective resolution.
  4. Monitor regulatory updates in EU and US markets, implementing necessary changes to maintain product compliance.
  5. Ensure effective lifecycle management for approved products, including post-approval changes, labeling updates, and CMC documentation.
  6. Oversee preparation and submission of eCTD for seamless regulatory filings.
  7. Collaborate with internal teams to strategize regulatory pathways, mitigate risks, and achieve optimal submission outcomes.
  8. Manage interactions with regulatory agencies, ensuring clear communication and efficient follow-up on submissions and queries.
  9. Maintain regulatory documentation, submission records, and ensure audit readiness.
  10. Provide regulatory guidance to internal teams to align development strategies with EU and US requirements.

What You Bring to the Team

  • M. Pharma with 10-12 years of relevant experience in Regulatory Affairs, focusing on EU & US markets
  • In-depth knowledge of regulatory submission processes and life cycle management
  • Strong expertise in responding to complex regulatory queries and handling post-approval changes.
  • A proactive, detail-oriented approach with the ability to independently manage multiple projects and deadlines.
  • Excellent written and verbal communication skills for clear interaction with regulatory authorities and internal stakeholders.

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