Job Title: Specialist – Regulatory Affairs LCM (Strategic Growth Products)
Location: Andheri (East), Mumbai, India (Hybrid)
Company: Advanz Pharma
Company Overview:
Advanz Pharma is a global pharmaceutical company committed to improving patients’ lives by providing and enhancing specialty, hospital, and rare disease medicines. Headquartered in London, UK, with operations in over 20 countries, Advanz Pharma partners with innovative biopharma companies to bring essential medicines to patients. The Mumbai Centre of Excellence supports regulatory compliance, lifecycle management, and global operations across multiple markets.
Business Unit Overview:
The Medical Office serves as a subject matter expert across global regulatory affairs, medical affairs, healthcare compliance, patient safety, and clinical development. The office represents the patient’s voice, ensures products retain a positive benefit/risk profile, drives scientific credibility, and maintains marketing authorizations worldwide.
Role Overview:
The Specialist, Regulatory Affairs LCM – Strategic Growth Products ensures timely lifecycle management (LCM) of Marketing Authorizations (MAs) for innovative medicines, biosimilars, and specialty generics. The role involves regulatory strategy execution, post-approval changes, and supply continuity while collaborating with cross-functional teams.
Key Responsibilities:
Support New Product Introduction (NPI) team during translation, labeling, and mock-up approvals; manage national phase procedures for DCPs.
Act as primary point of contact for Health Authorities post-MA grant.
Shadow Product Leads to gain knowledge of new MA procedures and Health Authority interactions.
Plan, strategize, and execute post-approval activities including:
Renewal Applications & Annual Maintenance
Variation Applications
Notification of marketing status changes & drug shortages
Tracking regulatory commitments & Specific Obligations for conditional products
PIP modifications, label updates, orphan designation maintenance, and NBO technical package updates
Serve as LCM product lead for assigned molecules globally; maintain and align regulatory submission plans and post-approval strategies.
Participate in cross-functional meetings (Change Control, SNOP, etc.) for assigned molecules.
Collaborate with SMEs from NPI and Innovative Medicines teams for strategy formation and review.
Support preparation for Scientific Advice meetings and market expansion applications.
Maintain handover documentation for transition to LCM Established Products.
Engage in M&A due diligence and integration for assets with Conditional or Exceptional Marketing Authorization.
Actively contribute to continuous improvement initiatives and process ownership.
Support readiness for health authority inspections; ensure timely completion of deviations and CAPAs.
Qualifications:
Graduate or Post-Graduate in Life Sciences, Pharmacy, or related discipline.
Formal training in Regulatory Affairs.
Knowledge, Skills & Experience:
Significant experience in LCM of pharmaceuticals in EU/UK and other regulated markets (Canada, Australia, New Zealand).
Proven biosimilars regulatory experience; experience with innovative medicines and complex post-approval CMC changes.
Strong knowledge of ICH clinical and safety guidelines; ability to interpret and apply independently.
Hands-on experience with CTD documentation and EU/UK regulatory procedures.
Experience interacting with EU/UK Health Authorities (Scientific Advice, Pre-submission meetings).
Document management and change control system proficiency.
Strong project management, communication, and stakeholder management skills.
Collaborative, strategic, solution-oriented, and able to work under pressure.
Excellent verbal and written communication skills; ability to present confidently to senior stakeholders.
Adaptable to evolving business needs, with a growth mindset aligned to Advanz Pharma’s values: entrepreneurship, speed, and integrity.
Why Advanz Pharma:
Work in a fast-paced, agile, inclusive environment with opportunities for personal and professional growth.
Contribute to global impact in specialty, hospital, and rare disease medicines.
Competitive salary, flexible working options, and comprehensive benefits.
Culture promotes diversity, inclusion, gender equality, and internal career growth.
Recognition for high performers via annual Impact Awards.
Application:
Submit your CV and cover letter online to join Advanz Pharma in improving patient outcomes worldwide.
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