Job Title: Specialist – Regulatory Affairs EU
Location: Andheri (East), Mumbai, India (Hybrid)
Employment Type: Temporary (6–8 months)
Company: Advanz Pharma
Company Overview:
Advanz Pharma is a global pharmaceutical company dedicated to improving patients’ lives by providing and enhancing specialty, hospital, and rare disease medicines. Headquartered in London, UK, and operating in over 20 countries, Advanz Pharma partners with innovative biopharma and pharmaceutical companies to bring essential medicines to patients worldwide. The Mumbai Centre of Excellence supports global operations and regulatory compliance across multiple markets.
Role Overview:
The Specialist, Regulatory Affairs EU will support the lifecycle management of Marketing Authorizations (MAs) for the EU portfolio. The role focuses on regulatory compliance, submission excellence, and process integration during mergers and acquisitions, ensuring supply continuity and timely regulatory approvals.
Key Responsibilities:
Drive integration activities during mergers & acquisitions, generating regulatory intelligence, supporting due diligence, and ensuring smooth regulatory transitions.
Review and provide oversight of regulatory submissions, ensuring “right first time” approvals and compliance with regional regulations.
Develop strategies for complex regulatory submissions and negotiate with health authorities as needed.
Handle complex regulatory submissions independently for assigned EU portfolio.
Act as process owner for cross-functional regulatory processes and identify areas for process improvement.
Disseminate regulatory updates, organize cross-functional discussions, and provide training as needed.
Participate in and prepare for health authority inspections.
Mentor and coach junior team members, support onboarding and induction programs.
Serve as deputy to Manager/Senior Manager during absences, representing the team in cross-functional meetings.
Qualifications & Experience:
Graduate/Post-Graduate in Life Sciences, Pharmacy, or related discipline.
Significant experience in EU regulatory affairs, particularly lifecycle maintenance activities in pharmaceutical companies.
Practical experience with CTD, eCTD, and modules 2–3 writing and review.
Commercial awareness and understanding of cross-functional dependencies.
Knowledge of regional regulatory guidelines, ICH standards, and EU requirements.
Strong project management, communication, and stakeholder management skills.
Positive, collaborative, strategic mindset with solution-oriented approach.
Ability to work effectively across global teams and multiple time zones.
Why Advanz Pharma:
Work in a fast-paced, agile, and inclusive environment with opportunities for personal and professional growth.
Be part of a global team driving innovation in specialty, hospital, and rare disease medicines.
Competitive salary, flexible working options, and comprehensive benefits package.
Culture promoting gender equality, diversity, and internal promotions.
Recognition for high performers through annual Impact Awards.
Application Process:
Submit your CV and cover letter online. Advanz Pharma is committed to equal employment opportunities and fostering an inclusive workplace.
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