Advanz Pharma Hiring in Regulatory Affairs

Advanz Pharma Hiring in Regulatory Affairs
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Advanz Pharma Hiring in Regulatory Affairs


Position: Specialist Regulatory Operations & Compliance (xEVMPD)

Organization: ADVANZ PHARMA

Qualification: B.Sc, M.Sc, B.Pharm, M.Pharm, Life Sciences

Experience: 1 – 4 Years

Salary: ₹4.8 Lakhs to ₹7.9 Lakhs per year

Location: Andheri, Mumbai (Hybrid working opportunity)


Key Responsibilities

  • Lead xEVMPD/IDMP submissions ensuring quality standards and deadlines are met.
  • Provide expertise on ISO IDMP Standards, EU Implementation Guide, and related regulatory requirements.
  • Develop and implement new regulatory processes and improve existing ones.
  • Ensure compliance with Electronic Document Management Systems and regulatory standards.
  • Maintain and track progress of regulatory submissions to ensure timely submissions.
  • Manage data migration, mapping, cleaning, and enrichment for IDMP.
  • Participate in system validation and implementation projects.
  • Train and support new users of regulatory systems.

Qualifications

  • Formal training in Regulatory Affairs.
  • Graduate/Post-graduate in any discipline of science, preferably life sciences or pharmacy.

Experience and Skills

Skill/ExperienceDescription
xEVMPD SubmissionsSignificant experience with xEVMPD submissions and EMA gateway maintenance.
Regulatory SystemsHands-on experience with regulatory systems validation and implementation for xEVMPD/ISO IDMP.
Submission RequirementsKnowledge of global electronic submission requirements.
Document ManagementFamiliarity with electronic Document Management Systems like Veeva Vault RIM.
Regulatory GuidelinesUnderstanding of ICH and regional regulatory guidelines.
Project ManagementStrong project management and communication skills.
CollaborationCollaborative and solution-oriented mindset.
Work EnvironmentAbility to work in a fast-paced, agile environment.
AttitudePositive attitude with a focus on continuous improvement and development.

Why ADVANZ PHARMA?

  • Empowerment to take ownership and embrace challenges.
  • Inclusive and respectful work environment.
  • Commitment to gender equality and promoting from within.
  • Recognition of talent through promotions and annual Impact Awards.
  • Competitive salary and benefits package.
  • Flexible, agile working options.
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