QRA/IRA Sr. Executive Job Opening at Noronic Pharmaceuticals

Noronic Pharmaceuticals, in collaboration with Neza Wellness, is inviting experienced professionals to join their Regulatory Affairs team as a QRA/IRA Senior Executive. This is an excellent opportunity for candidates with strong expertise in dossier preparation, ACTD/CTD compilation, regulatory documentation, PV data, SMPC drafting, and global regulatory submissions.

If you’re looking to grow your career in Regulatory Affairs, this role offers exposure to international markets, documentation management, and cross-functional collaboration—key skills for advancing in the pharma regulatory domain.

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⭐ Key Responsibilities

1. Dossier Preparation (ACTD/CTD)

• Prepare, compile, and review:
  • ACTD & CTD modules
  • Pharmacovigilance documentation
  • Stability data & reports
  • SPECT/Specifications
  • COA/MOA
  • SMPC
  • BE study review
  • PDR
  • AMV
  • DMF
  • BMR & BPR
  • BIT form
  • CDP matching

2. Regulatory Documentation & Approvals

• Prepare and submit:
  • COPP
  • PP
  • FSC certification
• Manage timely approvals, renewals, and follow-ups.

3. Regulatory Queries & Communication

• Handle country-specific regulatory authority queries.
• Coordinate with international agencies and internal teams.

4. Cross-Functional Coordination

• Work closely with QA, QC, Production, R&D, and Marketing.
• Ensure all required documentation is accurate and compliant.

5. Compliance & Continuous Improvement

• Stay updated with global regulatory guidelines.
• Support dossier upgrades and SOP improvements.

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⭐ Eligibility & Qualifications

• Experience: Only experienced candidates can apply.
• Education:
  • B.Sc / M.Sc
  • B.Pharm / M.Pharm
• Strong knowledge of ACTD/CTD formats, regulatory submissions, and documentation.

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⭐ Preferred Skills

• Knowledge of global regulatory requirements
• Expertise in dossier lifecycle management
• Strong documentation and communication skills
• Ability to coordinate with cross-functional teams
• Understanding of QA/QC documentation

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⭐ Benefits

• Opportunity to work with leadership-level regulatory professionals
• Exposure to global regulatory markets
• Skill enhancement through cross-functional collaboration
• Career progression in regulatory affairs

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⭐ How to Apply

Send your updated resume/CV to:

📧 hr@noronicpharma.com