Regulatory Affairs Specialist at Advanz Pharma
Advanz Pharma is looking for a skilled Specialist in Regulatory Affairs (EU) for a temporary 6–8 month role based in Andheri, Mumbai. This Regulatory Affairs Job hybrid opportunity is ideal for experienced regulatory professionals who can manage life cycle maintenance, regulatory submissions, and integration activities for EU/UK/IE markets. Graduates seeking for B pharma jobs or M Pharma jobs can apply now .
Introduction of the Job
Advanz Pharma is offering a temporary 6–8 month role for a Specialist in Regulatory Affairs EU, based in Andheri, Mumbai. This hybrid role supports EU/UK/IE regulatory operations, integration activities, and life cycle management of Marketing Authorizations.
Job Details for Regulatory Affairs Job Role:
Position: Specialist – Regulatory Affairs EU
Type: Temporary (6–8 Months)
Location: Andheri (East), Mumbai (Hybrid)
Key Responsibilities for Regulatory Affairs Job Role:
- Drive integration activities following mergers & acquisitions.
- Generate regulatory intelligence and support due diligence.
- Manage complex regulatory submissions and build regulatory strategies.
- Handle life cycle maintenance activities for EU/UK/IE Marketing Authorizations.
- Review regulatory applications and ensure right-first-time submissions is required for Regulatory Affairs Job Role.
- Act as process owner for regulatory-driven cross-functional processes.
- Communicate regulatory updates and support compliance.
- Participate in health authority inspections.
- Coach junior team members and support induction.
- Act as deputy to the Manager/Sr. Manager during absences.
About the Company
Advanz Pharma is a global pharmaceutical organization focused on specialty, hospital, and rare disease medicines. With operations across 20+ countries and a strong Center of Excellence in Mumbai, the company partners with biopharma innovators to bring critical therapies to patients. Its culture emphasizes entrepreneurship, speed, integrity, and diversity.
Educational Requirements :
-
Graduate/Post-Graduate in Life Sciences / Pharmacy or any science discipline.
Skills & Experience Required for Regulatory Affairs Job Role:
- Strong experience in EU/UK/IE regulatory affairs.
- Practical knowledge of CTD Modules 2–3 writing and review.
- Understanding of ICH/eCTD and regional guidelines.
- Project management and communication skills.
- Ability to handle complex submissions independently.
- Strategic mindset, commercial awareness, and cross-functional collaboration.
- Problem-solving, decision-making, and a proactive approach.
Skills Required for Regulatory Affairs Job Role:
- EU regulatory expertise
- CTD/eCTD writing and review
- Lifecycle management
- M&A integration understanding
- Regulatory strategy building
- Cross-functional communication
- Coaching & leadership support
How to Apply for Regulatory Affairs Job Role:
Graduates seeking for B pharma jobs or M Pharma jobs can apply now with your CV and Cover Letter through the official Advanz Pharma careers portal or application link provided in the job posting.
