Specialist Regulatory Affairs LCM – Strategic Growth Products
Company: Advanz Pharma
Location: Andheri (East), Mumbai, India
Work Mode: Hybrid
Job Type: Full-Time
Experience Required: 5–9 years in Regulatory Affairs Life Cycle Management (EU/UK focus)
Date Posted: 24 January 2026
About Advanz Pharma
Advanz Pharma is a global pharmaceutical organization dedicated to improving patient outcomes by providing and enhancing specialty, hospital, and rare disease medicines. Headquartered in London, UK, the company operates across 20+ countries, including key markets in Europe, the US, Canada, Australia, and India.
With a strong Centre of Excellence in Mumbai and an established global distribution and commercialization network, Advanz Pharma partners with innovative biopharma and pharmaceutical development companies to bring high-quality medicines to patients worldwide.
The company’s portfolio spans innovative medicines, biosimilars, specialty generics, and originator brands, covering therapeutic areas such as hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and rare diseases. Advanz Pharma is driven by its core values of entrepreneurship, speed, and integrity.
About the Medical Office
The Medical Office at Advanz Pharma provides regulatory, medical, scientific, clinical, and drug safety expertise across the organization. The function plays a critical role in securing and maintaining marketing authorizations globally, ensuring regulatory compliance, scientific credibility, and patient-centric decision-making throughout the product life cycle.
Role Overview
Advanz Pharma is seeking a Specialist – Regulatory Affairs Life Cycle Management (LCM) to support Strategic Growth Products, including innovative medicines, biosimilars, and specialty generics.
The primary objective of this role is to ensure timely and compliant post-approval life cycle management of Marketing Authorizations, with a strong focus on supply continuity, regulatory compliance, and cross-functional collaboration across global markets.
This position requires deep expertise in EU/UK regulatory procedures, particularly for biosimilars and complex post-approval changes, and close engagement with health authorities and internal stakeholders.
Key Responsibilities
Support New Product Introduction (NPI) activities, including label finalization, translations, and mock-ups, to secure regulatory approvals.
Act as the primary regulatory contact for Health Authorities post-Marketing Authorization approval.
Manage national phase procedures for DCP submissions and coordinate interactions with regulatory agencies.
Lead and execute life cycle management activities, including:
Renewals and annual maintenance submissions
Variations and post-approval changes
Marketing status notifications and sunset clause exemptions
Drug shortage notifications
Tracking and fulfillment of post-approval commitments and specific obligations
PIP compliance, modifications, and related labeling updates
Orphan designation maintenance and NBO technical package updates (where applicable)
Serve as LCM Product Lead for assigned molecules (primarily biosimilars) across global markets.
Develop and align regulatory submission plans and post-approval strategies with cross-functional teams.
Participate in cross-functional governance forums such as Change Control and S&OP meetings.
Contribute to Scientific Advice preparation and meetings with regulatory authorities as required.
Support market expansion activities, including regulatory submissions to new territories.
Maintain structured handover documentation for transition to established product teams.
Support regulatory due diligence and integration activities related to M&A, where applicable.
Actively participate in continuous improvement initiatives, inspections, CAPAs, and deviation management.
Qualifications
Graduate or Postgraduate in Life Sciences, Pharmacy, or related scientific discipline.
Formal training or certification in Regulatory Affairs is preferred.
Experience, Knowledge & Skills
5–9 years of hands-on experience in Regulatory Affairs Life Cycle Management within EU/UK and other regulated markets (Canada, Australia, New Zealand).
Proven experience in biosimilars regulatory life cycle activities (EU focus preferred).
Strong understanding of ICH clinical and safety guidelines and their practical application.
In-depth knowledge of EU/UK regulatory procedures, CTD structure, and submission processes.
Experience interacting with regulatory authorities through Scientific Advice and pre-submission meetings.
Exposure to innovative medicines and complex CMC post-approval changes.
Hands-on experience with document management systems and change control workflows.
Excellent project management, communication, and stakeholder management skills.
Ability to work independently, manage multiple priorities, and adapt in a fast-paced environment.
Strong written and verbal communication skills, including senior-level presentations.
Collaborative, solution-oriented mindset aligned with Advanz Pharma’s values.
Why Join Advanz Pharma?
Join a fast-growing global pharmaceutical company with a strong specialty and rare disease focus.
Work in a hybrid, agile, and inclusive environment that values innovation and ownership.
Benefit from career growth opportunities, internal promotions, and global exposure.
Be part of a diverse workforce committed to integrity, entrepreneurship, and patient impact.
Receive a competitive compensation and benefits package.
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