Advanz Pharma Hiring in Regulatory Affairs

About Company

ADVANZ PHARMA is a global pharmaceutical company dedicated to improving patients’ lives by providing and enhancing specialty, hospital, and rare disease medicines. We partner with innovative biopharma and pharmaceutical companies to bring vital medicines to patients across Europe, Canada, and Australia. Our headquarters are in London, UK, and we have approximately 700 employees in over 20 countries, including a Centre of Excellence in Mumbai, India. Our portfolio includes innovative medicines, specialty generics, biosimilars, and originator brands across a broad range of therapeutic areas.

Position Name : Specialist Regulatory Operations & Compliance (xEVMPD)

Organization : ADVANZ PHARMA

Qualification: B.Sc, Msc, B.Pharm , M.Pharm, Lifesciences

Experience: 1 – 4 Years

Salary: ₹4.8 Lakhs to ₹7.9 Lakhs per year.

Location: Andheri, Mumbai (Hybrid working opportunity)

As ADVANZ PHARMA continues to expand, we are looking for a Specialist in Regulatory Operations & Compliance to join our team. The role involves coordinating and managing xEVMPD/IDMP submissions, ensuring compliance with electronic submission standards, and supporting regulatory systems processes.

Key Responsibilities:

Lead xEVMPD/IDMP submissions and ensure they meet quality standards and deadlines.
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 and 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:

Significant experience with xEVMPD submissions and EMA gateway maintenance.
Hands-on experience with regulatory systems validation and implementation for xEVMPD/ISO IDMP.
Knowledge of global electronic submission requirements.
Familiarity with electronic Document Management Systems like Veeva Vault RIM.
Understanding of ICH and regional regulatory guidelines.
Strong project management and communication skills.
Collaborative and solution-oriented mindset.
Ability to work in a fast-paced, agile environment.
Positive attitude with a focus on continuous improvement and development.

Why ADVANZ PHARMA?