Specialist – Regulatory Affairs (EU)
Company: ADVANZ PHARMA
Location: Andheri (East), Mumbai, India
Work Mode: Hybrid
Employment Type: Temporary (6–8 Months)
Experience Required: 5–8 Years
Date Posted: 20 December 2025
Job Overview
ADVANZ PHARMA is seeking an experienced Specialist, Regulatory Affairs (EU) to support lifecycle management activities for its European portfolio. This temporary position is based in Mumbai and offers a hybrid working model.
The role is critical to ensuring regulatory compliance, supply continuity, and timely lifecycle maintenance of Marketing Authorizations (MAs) across EU markets. The successful candidate will work closely with regional and cross-functional teams, contribute to regulatory strategy, and play a key role in integration activities following mergers and acquisitions.
Key Responsibilities
Regulatory Lifecycle Management
Manage and execute lifecycle maintenance activities for assigned EU Marketing Authorizations
Ensure regulatory compliance, timely approvals, and uninterrupted product supply
Independently handle complex regulatory submissions with a “right-first-time” approach
Mergers & Acquisitions Integration
Drive regulatory integration activities during M&A transitions
Generate regulatory intelligence for pre-integration and due diligence activities
Project manage regulatory submissions during transition phases and ensure smooth handover to lifecycle management teams
Regulatory Strategy & Submissions
Review and add value to regulatory applications prepared by team members
Develop regulatory strategies for complex submissions and lead discussions with EU health authorities
Interpret and apply EU regulatory guidelines, CTD, ICH, and eCTD requirements
Negotiate with health authorities when required, aligning regulatory outcomes with business objectives
Process Ownership & Compliance
Act as process owner for complex regulatory and cross-functional processes
Identify opportunities for process improvement and simplification
Maintain oversight of regulatory intelligence and disseminate updates across teams
Support legislative compliance initiatives and cross-functional training sessions
Leadership & Collaboration
Support and mentor junior regulatory team members
Act as delegate to the Manager/Senior Manager during absences
Participate in cross-functional forums such as QRST, SNOP, and change control approvals
Support preparation and participation in health authority inspections and audits
Required Qualifications
Education:
Graduate or Postgraduate degree in Life Sciences, Pharmacy, or a related scientific discipline
Experience & Skills Required
Experience:
5–8 years of hands-on regulatory affairs experience in EU/UK/Ireland markets
Proven experience in lifecycle maintenance activities in a pharmaceutical company
Experience working in a doer/reviewer capacity as an individual contributor
Technical Expertise:
Strong working knowledge of CTD modules (especially Modules 2 & 3)
Practical experience with EU regulatory guidelines, ICH, and eCTD submissions
Solid understanding of cross-functional dependencies and commercial impact
Core Competencies:
Strong project management and communication skills
Strategic mindset with solution-oriented decision-making ability
High attention to detail with a focus on regulatory excellence
Ability to work effectively in fast-paced, changing environments
Personal Attributes
Collaborative and professional approach with a positive attitude
Strong sense of ownership, urgency, and accountability
Adaptable, proactive, and motivated to drive continuous improvement
Aligned with ADVANZ PHARMA’s values of entrepreneurship, speed, and integrity
About ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical company dedicated to improving patients’ lives by delivering specialty, hospital, and rare disease medicines. Headquartered in London, the company operates across Europe, North America, Australia, and India, supported by a strong Centre of Excellence in Mumbai.
The company’s portfolio spans multiple therapeutic areas including hepatology, gastroenterology, endocrinology, CNS, critical care, anti-infectives, and rare diseases.
Why Join ADVANZ PHARMA
Opportunity to work on EU regulatory portfolios within a global organization
Exposure to complex regulatory strategy and M&A integration activities
Flexible hybrid working environment
Competitive compensation and benefits package
Inclusive culture with strong focus on internal growth and leadership development
Application Process
Interested candidates are encouraged to apply with:
Updated CV
Cover Letter
SEO Keywords Optimized
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