Regulatory Affairs Jobs: Advanz Pharma is Hiring a Specialist | Apply Now
Looking to advance your regulatory career in a fast-growing global pharma company? Advanz Pharma is hiring a Specialist in Regulatory Affairs LCM for its Strategic Growth Products team in Mumbai. This role is perfect for professionals passionate about Regulatory Affairs jobs, lifecycle management, and impactful life science careers that directly support patient access to critical therapies. If you want to work with innovative medicines, biosimilars, complex generics, and global health authorities, this position is a career-defining opportunity.
Job Details:
- Job Title: Specialist Regulatory Affairs LCM – Strategic Growth Products
- Location: Andheri (East), IN, Mumbai 400
About the Company
ADVANZ PHARMA is a global pharmaceutical organisation dedicated to improving patient lives by strengthening access to specialty, hospital, and rare disease medicines. Headquartered in London and operating across more than 20 countries, the company has earned a strong reputation as a trusted partner for the commercialisation of complex therapies. Its growing presence in Europe, Canada, Australia, and key global markets makes it an important employer for professionals seeking impactful life science jobs and long-term career growth.
With an extensive portfolio that includes innovative medicines, biosimilars, specialty generics, and originator brands, ADVANZ PHARMA supports a broad range of therapeutic areas—such as hepatology, gastroenterology, critical care, endocrinology, CNS, anti-infectives, and rare diseases. The organisation collaborates closely with biopharma innovators to bring essential and often hard-to-access treatments to patients worldwide.
A key strength is its Centre of Excellence in Mumbai, which supports major global functions including regulatory affairs, medical operations, drug safety, clinical development, and supply chain. This hub plays an important role in advancing the company’s mission while offering excellent opportunities for professionals exploring Regulatory Affairs jobs in India or internationally.
Key Responsibilities
- Lead lifecycle maintenance activities for global Marketing Authorisations
- Support New Product Introduction team during translation and label finalisation
- Act as primary point of contact with EU/UK health authorities post MA grant
- Drive renewal, variation, and annual maintenance submissions
- Manage post-approval activities including drug shortages, commitments, PIP compliance
- Maintain regulatory submission plans and cross-functional alignment
- Participate in scientific advice meetings with health authorities
- Support market expansion activities in new territories
- Ensure high-quality regulatory documentation and Change Control participation
- Contribute to inspection readiness and continuous improvement initiatives
Qualifications:
- Graduate or post-graduate in any discipline of Science, preferably life science.
- Formal training in Regulatory Affairs
Skills Required
- Strong understanding of EU/UK regulatory procedures
- Proven experience in biosimilars & lifecycle regulatory activities
- Knowledge of ICH clinical and safety guidelines
- Hands-on experience with CTD, document management systems, and change control
- Excellent communication & cross-functional collaboration
- Strategic thinking, decision-making, and ability to work under pressure
- Positive attitude, agility, and solution-oriented mindset
This is a high-impact opportunity for regulatory professionals seeking meaningful Regulatory Affairs jobs within a global organisation that values expertise, innovation, and patient-centricity. If you’re looking to grow your career in a collaborative and forward-thinking environment, Advanz Pharma offers the platform, purpose, and global exposure you need. Step into a role where your knowledge genuinely makes a difference.
