Regulatory Affairs LCM Specialist Job at ADVANZ Pharma Mumbai
ADVANZ PHARMA is hiring a Specialist in Regulatory Affairs LCM for its Strategic Growth Products division in Mumbai. This Regulatory Affairs Job hybrid role focuses on lifecycle management, regulatory submissions, biosimilar support, post-approval activities, and global regulatory alignment across EU/UK and other regulated markets. Graduates seeking for B pharma jobs or M Pharma jobs can apply now.
Introduction of the Job
ADVANZ PHARMA is looking for a highly skilled Regulatory Affairs LCM Specialist to support lifecycle management, ensure regulatory compliance, manage global post-approval activities, and act as a regulatory point of contact across markets. This Regulatory Affairs Job role supports biosimilars, innovative medicines, and specialty generics.
Job Details for Regulatory Affairs Job Role:
Position: Specialist – Regulatory Affairs LCM (Strategic Growth Products)
Location: Andheri (East), Mumbai – Hybrid
Posting Date: 27 November 2025
Company: ADVANZ PHARMA
Job Category: Regulatory Affairs
Schedule: Full Time
Job Type: LCM – Strategic Growth Products
About the Company – ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical leader focused on specialty, rare disease, and hospital medicines. With 700+ employees across 20+ countries, including a Centre of Excellence in Mumbai, the company partners with innovative biotech organizations to bring vital therapies to patients across Europe, Canada, and Australia. ADVANZ PHARMA emphasizes entrepreneurship, speed, integrity, and scientific excellence.
Educational Requirements for Regulatory Affairs Job Role:
- Graduate or Postgraduate in Pharmacy
- Formal training in Regulatory Affairs preferred
Key Responsibilities for Regulatory Affairs Job Role:
Lifecycle Maintenance & Post-Approval Activities
- Ensure timely lifecycle management for Marketing Authorizations (MAs).
- Focus on supply continuity and compliance with regulatory requirements.
- Manage renewals, variations, drug shortage notifications, and sunset clause exemptions.
- Handle PIP modifications, PIP compliance, and orphan designation maintenance.
Support for New Product Introduction (NPI) for Regulatory Affairs Job Role:
- Assist NPI team with translation, product labels, and mock-ups.
- Manage national phase procedures for DCPs.
- Be the primary Health Authority contact post-MA approval.
- Shadow Product Lead to understand MA processes, commitments, negotiations, and HA interactions.
Strategic Role for Biosimilars & Growth Products
- Act as global LCM Product Lead for assigned molecules, primarily biosimilars.
- Participate in cross-functional teams: Change Control, Supply Chain, SNOP, Medical, Technical, Commercial.
Regulatory Strategy & Documentation for Regulatory Affairs Job Role:
- Maintain regulatory submission plans and post-approval strategies.
- Prepare meeting packages for Scientific Advice and participate in discussions.
- Support market expansion activities for new territories.
- Maintain handover documents for transition to LCM Established Products.
Additional Responsibilities
- Contribute to continuous improvement initiatives.
- Act as process owner for regulatory procedures when delegated.
- Support inspection readiness, manage deviations and CAPAs.
- Participate in due diligence for M&A assets with conditional marketing approvals.
Skills Required for Regulatory Affairs Job Role:
- Strong experience in LCM for EU/UK and regulated markets (Canada, Australia, NZ).
- Proven biosimilars lifecycle management experience.
- Knowledge of ICH clinical & safety guidelines.
- Hands-on expertise with CTD, CMC post-approval activities.
- Experience interacting with EU/UK authorities (scientific advice, pre-submission).
- Strong project management, documentation, and change control systems.
- Excellent verbal & written communication skills.
- Strategic mindset, collaborative personality, problem-solving ability.
- Ability to adapt, prioritize, and work in dynamic environments.
- Alignment with values: entrepreneurship, speed, integrity.
About the Team
The Medical Office brings regulatory, medical, scientific, safety, and compliance expertise to ADVANZ PHARMA. It ensures scientific credibility, patient-centric decision-making, regulatory excellence, and compliance across global operations. Regulatory Affairs Job role plays a significant role in the company.
Why Work at ADVANZ PHARMA?
- Entrepreneurial, fast-paced, inclusive culture
- Highly diverse and global workforce
- Strong focus on internal growth and promotions (25% promoted last year)
- Flexible and agile working options
- Competitive salary and benefits
- Women’s leadership initiatives (40%+ women managers)
- Recognitions through annual Impact Awards
How to Apply for Regulatory Affairs Job Role:
Graduates seeking for B pharma jobs or M Pharma jobs can apply now. Submit your CV and Cover Letter through the official ADVANZ PHARMA application link.