Specialist Regulatory Affairs – Life Cycle Management (LCM), Strategic Growth Products | Advanz Pharma
Location: Andheri (East), Mumbai, India (Hybrid Working Opportunity)
Company: Advanz Pharma
About Advanz Pharma
Advanz Pharma is a global pharmaceutical company dedicated to improving patient lives by providing and enhancing specialty, hospital, and rare disease medicines. With operations spanning Europe, Canada, Australia, and India, Advanz Pharma partners with innovative biopharma and pharmaceutical companies to bring critical medicines to patients worldwide.
Headquartered in London, UK, Advanz Pharma employs approximately 700 professionals across 20+ countries. Its Centre of Excellence in Mumbai supports global regulatory, commercialization, and distribution operations. The company’s portfolio includes innovative medicines, biosimilars, specialty generics, and originator brands, spanning therapeutic areas such as hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and rare diseases.
Advanz Pharma fosters a culture of entrepreneurship, speed, and integrity, empowering employees to drive results while maintaining high regulatory and ethical standards.
Role Overview
The Specialist Regulatory Affairs – LCM is responsible for the life cycle management of Strategic Growth Products, including Innovative Medicines, Biosimilars, and Specialty Generics. This role ensures compliance with regulatory requirements, manages post-approval activities, and supports supply continuity across global markets.
The role involves collaboration with internal functions (Quality, Supply Chain, Technical, Medical, and Commercial) and external stakeholders (regulatory authorities and product developers) to maintain and optimize product registrations and marketing authorizations.
Key Responsibilities
Life Cycle Management (LCM):
Execute post-approval regulatory activities for assigned molecules, including renewal applications, variations, notifications of change, and maintenance of orphan designation or PIP compliance.
Act as the primary point of contact with Health Authorities post-approval, coordinating interactions and regulatory submissions.
Support New Product Introduction teams during translation, label finalization, and product mock-ups.
Manage regulatory submissions for market expansion and new territory approvals.
Track and fulfill regulatory commitments, including Specific Obligations for conditionally or exceptionally approved products.
Strategic & Cross-Functional Collaboration:
Participate in cross-functional meetings such as Change Control, SNOP, and project updates for assigned molecules.
Work closely with New Products, Innovative Medicines, and Specialty Generics teams to define regulatory strategy and maintain alignment throughout the product life cycle.
Contribute to scientific advice meetings and preparation of regulatory packages.
Regulatory Compliance & Documentation:
Maintain regulatory dossiers, CTD submissions, and document management systems.
Ensure compliance with EU, UK, and other regulated markets (Canada, Australia, New Zealand).
Support readiness for regulatory inspections and audits.
Participate in continuous improvement initiatives and process optimization.
Candidate Profile
Education & Qualifications:
Graduate or Postgraduate in Science, preferably Life Sciences or Pharmacy.
Formal regulatory affairs training is preferred.
Experience Required:
Significant experience in life cycle management (LCM) of pharmaceuticals, including Biosimilars, Innovative Medicines, or Specialty Generics.
Hands-on experience with EU/UK regulatory procedures, post-approval submissions, and regulatory authority interactions.
Strong understanding of ICH clinical and safety guidelines, CTD dossiers, and CMC post-approval changes.
Skills & Competencies:
Strong project management and communication skills; able to present confidently to senior stakeholders.
Strategic mindset with a collaborative and solution-oriented approach.
Ability to make informed decisions based on regulatory data, trends, and business objectives.
Flexibility to adapt in a dynamic, fast-paced environment.
Proficiency in document management, change control systems, and MS Office applications.
Positive attitude, entrepreneurial mindset, and alignment with Advanz Pharma’s values of entrepreneurship, speed, and integrity.
Why Join Advanz Pharma?
Work in an inclusive, agile, and high-growth environment empowering employees to take ownership and innovate.
Flexible hybrid working options, competitive salary, and benefits package.
Opportunities for career growth, promotions, and recognition through awards and internal development programs.
Join a global team passionate about improving patient outcomes and advancing specialty and hospital medicines.
Be part of a company that actively promotes gender equality, diversity, and collaboration across international teams.
Application:
Interested candidates should submit a CV and Cover Letter.
Advanz Pharma is an equal opportunity employer, committed to fostering diversity and inclusion. All applications are considered without regard to race, gender, age, disability, sexual orientation, or other protected characteristics.
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