Regulatory Affairs Jobs: Advanz Pharma is Hiring a Senior Executive | Apply Now for Pharmacy Jobs
Advanz Pharma is seeking for a Senior Executive – Regulatory Affairs Role at its Mumbai (Andheri East) office. This temporary 8-month role (hybrid) offers an exciting opportunity to manage regulatory submissions, life-cycle maintenance, and compliance for specialty, hospital, and rare disease medicines in the European market. If you are passionate about regulatory science and ensuring patient access to innovative medicines, Apply Now for Pharmacy Jobs; this role is for you.
About Advanz Pharma:
Advanz Pharma is a global pharmaceutical company dedicated to improving patients’ lives by providing specialty, hospital, and rare disease medicines. Headquartered in London, UK, the company operates across 20+ countries, including Europe, the US, Canada, and Australia. Advanz Pharma partners with innovative biopharma and pharmaceutical development companies to bring medicines to patients.
The Mumbai Centre of Excellence supports global operations with regulatory, distribution, and commercialization expertise. Its diverse product portfolio covers hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and rare diseases, combining innovative medicines, specialty generics, biosimilars, and originator brands.
Job Details:
- Job Position: Senior Executive – Regulatory Affairs (EU)
- Location: Andheri (East), Mumbai, India
- Job Type: Hybrid
- Job Type: Temporary – 8 months
About the Regulatory Affairs Role:
The Senior Executive – Regulatory Affairs (EU) will play a critical role in life-cycle management of pharmaceuticals, ensuring regulatory compliance, timely submissions, and supply continuity across the European market.
Education:
Graduate/Post-Graduate in science or life sciences (Pharmacy preferred)
Key Responsibilities for the Regulatory Affairs Role:
- Plan and prepare renewals/annual maintenance of Marketing Authorizations (MA).
- Ensure timely regulatory submissions with “right-first-time” approach.
- Review documents to comply with regulatory requirements and proactively manage approvals.
- Assess change requests, variations, and regulatory strategy for assigned products.
- Manage submission of Article 61(3) updates, MAH Transfers, PSURs, and other regulatory obligations.
- Provide peer review support for submissions by other executives.
- Maintain compliance with departmental procedures and training records.
- Drive continuous improvement initiatives and moderate regulatory projects.
- Act as process owner for regulatory procedures and support health authority inspections.
- Support integration and maintenance of acquired products throughout their lifecycle.
- Ensure timely completion of Deviations and CAPAs.
- Promote company values of entrepreneurship, speed, integrity, and “One Team” collaboration.
Skills Required:
- Formal training in Regulatory Affairs
- Significant experience in EU life-cycle management of pharmaceuticals
- Expertise in CTD submissions, particularly Module 3, and practical experience with Module 1 and labeling requirements
- Knowledge of ICH and EU regulatory guidelines, safety variation submissions, RFIs, and document management systems
- Strong project management, communication, and collaboration skills
- Positive, solution-oriented mindset with learning agility and scalability
- Ability to thrive in a hybrid, fast-paced, and inclusive environment
