Advanz Pharma Hiring Regulatory Affairs Specialist
- Regulatory Affairs Specialist – Advanz Pharma Mumbai | B.Pharm / M.Sc
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Location & Work Type
- Why Join Advanz Pharma?
- Application Process
- FAQs – Regulatory Affairs Specialist at Advanz Pharma
Regulatory Affairs Specialist – Advanz Pharma Mumbai | B.Pharm / M.Sc
Apply for Specialist Regulatory Affairs LCM role at Advanz Pharma, Mumbai. Open for Life Science, Pharmacy graduates with regulatory experience.
Advanz Pharma is hiring a Specialist – Regulatory Affairs LCM (Strategic Growth Products) in Mumbai (Andheri East). This hybrid role offers an exciting opportunity to manage global regulatory submissions, life cycle management, and post-approval strategies for innovative and specialty medicines across EU, UK, and other regulated markets.
Company Overview
Advanz Pharma is a global specialty pharmaceutical company with headquarters in London, UK, and a strong presence in over 20 countries, including Canada, Australia, and India. The company focuses on improving patients’ lives by providing and enhancing access to specialty, hospital, and rare disease medicines.
Its product portfolio includes specialty generics, biosimilars, and originator brands, covering key therapeutic areas like hepatology, gastroenterology, endocrinology, CNS, and rare diseases. With its Centre of Excellence in Mumbai, Advanz Pharma combines science, innovation, and global collaboration to enhance healthcare outcomes.
Job Role & Responsibilities
As a Regulatory Affairs Specialist, you will support life cycle maintenance (LCM) activities for marketed products and ensure regulatory compliance across multiple geographies. The role requires strategic coordination, project management, and communication with internal and external stakeholders.
Key Responsibilities:
- Manage life cycle maintenance (LCM) activities for global Marketing Authorizations (MA).
- Ensure regulatory compliance, supply continuity, and timely renewals and variations.
- Lead submission of post-approval changes including PIP modifications, renewals, variations, and status notifications.
- Serve as a primary liaison with Health Authorities and internal teams post Marketing Authorization.
- Collaborate with New Product Introduction (NPI) and cross-functional teams (Quality, Medical, Supply Chain, Commercial) for label finalization and translation approvals.
- Track and fulfill regulatory commitments, including those for conditionally or exceptionally approved products.
- Prepare scientific advice packages and participate in regulatory strategy discussions.
- Support due diligence and integration for M&A activities involving conditional or exceptional approvals.
- Ensure timely completion of Deviation and CAPA documentation.
- Participate in continuous improvement initiatives and process ownership within Regulatory Affairs.
Eligibility / Qualifications
Educational Requirements:
- Graduate or Postgraduate in Pharmacy, Life Sciences, or related scientific discipline.
- Formal training in Regulatory Affairs preferred.
Experience:
- Hands-on experience managing regulatory submissions and life cycle management in EU/UK or other regulated markets (Canada, Australia, NZ).
- Familiarity with ICH Clinical and Safety Guidelines, CTD format, and label updates.
- Experience interacting with Health Authorities for scientific or pre-submission meetings.
- Prior experience handling innovative and specialty medicines is an advantage.
Skills:
- Strong communication and analytical skills.
- Excellent medical writing and document review proficiency.
- Strategic mindset with ability to make informed decisions.
- Experience using document management systems and change control systems.
- Ability to thrive in a matrix environment and work cross-functionally.
Location & Work Type
Location: Andheri (East), Mumbai, India
Work Type: Hybrid (Office + Remote)
Job Type: Full-time
Salary: Competitive, based on experience and market standards
Why Join Advanz Pharma?
- Be part of a global pharmaceutical company with a mission to advance healthcare accessibility.
- Engage in strategic, high-impact regulatory projects across multiple markets.
- Experience a culture built on entrepreneurship, speed, and integrity.
- Enjoy opportunities for career growth, training, and internal promotions.
- Work in an inclusive environment that values diversity, innovation, and personal development.
Application Process
Interested candidates can apply through the Advanz Pharma Careers Portal by submitting their updated resume and cover letter.
Apply before October 31, 2025, to be part of a dynamic global team driving regulatory excellence!
FAQs – Regulatory Affairs Specialist at Advanz Pharma
Q1. What qualifications are required?
Candidates should hold a degree in Pharmacy or Life Sciences with regulatory experience.
Q2. Is prior EU/UK regulatory experience mandatory?
Yes, experience in EU/UK life cycle management and regulatory submissions is preferred.
Q3. What type of work environment does Advanz Pharma offer?
A hybrid, collaborative, and fast-paced work culture promoting professional growth.
Q4. What therapeutic areas does Advanz Pharma focus on?
The company covers hepatology, CNS, endocrinology, gastroenterology, rare diseases, and more.
Q5. How can I apply?
Apply through the Advanz Pharma Careers Portal with a resume and cover letter.
Markdown Summary Table
| Company | Advanz Pharma |
| Vacancies | Specialist – Regulatory Affairs LCM (Strategic Growth Products) |
| Required Education | B.Pharm, M.Pharm, M.Sc, Life Sciences |
| Experience | 3–8 years in Regulatory Affairs / Life Cycle Management |
To apply for this job please visit www.advanzpharma.com.