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Advanz Pharma, a global pharmaceutical leader, is seeking a Regulatory Affairs Specialist for its Andheri (East), Mumbai office. This temporary 6–8 month role offers hybrid working flexibility and the opportunity to contribute to the life cycle management of specialty, hospital, and rare disease medicines. If you are passionate about regulatory compliance and ensuring smooth supply continuity, this could be your ideal career move.
Key Responsibilities
As a Regulatory Affairs Specialist, you will:
- Drive integration activities post-merger & acquisition, providing regulatory intelligence and project management support.
- Support review of applications and submissions with a focus on “right first time” and compliance with UK/IE/EU regulations.
- Build regulatory strategies for complex submissions, negotiate with health authorities, and handle approvals independently when needed.
- Act as process owner for cross-functional regulatory processes, implementing improvements and ensuring legislative compliance.
- Prepare for and participate in health authority inspections.
- Mentor junior team members and assist in onboarding new hires.
- Act as deputy to the Manager/Sr. Manager during absences, including approving change controls and artworks.
Qualifications & Experience
- Educational Qualification: Graduate/Post-Graduate in Life Sciences or Pharmacy.
- Experience: Significant hands-on experience in regulatory affairs, particularly in life cycle maintenance in the UK/IE/EU markets.
- Technical Skills:
- Expertise in CTD (Module 2-3) writing and review.
- Knowledge of ICH, eCTD, and regional regulatory guidelines.
- Soft Skills: Strong project management, strategic mindset, excellent communication, solution-oriented, collaborative, and positive attitude.
Benefits
- Competitive salary and benefits package (INR 70,000–1,00,000/month).
- Hybrid working flexibility.
- Opportunity to work with a global pharmaceutical company in rare disease and specialty medicines.
- Inclusive and empowering work culture, gender equality initiatives, and professional growth opportunities.
- Recognition programs including annual Impact Awards and internal promotions.
How to Apply
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