Regulatory Affairs Jobs at Advanz: Hiring in Mumbai | Apply for Pharmacy Jobs
Are you currently looking for Pharmacy Jobs? Here is an opportunity. Advanz Pharma is seeking a Specialist Regulatory Affairs LCM in Mumbai, Maharashtra, for a hybrid full-time position. This role offers an exciting opportunity to work on the life cycle management of specialty, hospital, and rare disease medicines while ensuring global regulatory compliance. If you are passionate about advancing patient care and have strong expertise in pharmaceutical regulations, this could be your next career move. Apply Online for the Regulatory Affairs Jobs at Advanz and head towards a successful career.
Job Details:
- Job Title: Specialist Regulatory Affairs LCM
- Location: Andheri, Mumbai
- Work Type: Hybrid | Full-time
About the Company:
ADVANZ PHARMA is a global pharmaceutical company headquartered in London, UK, with a strong presence in over 90 countries. The company specializes in specialty, hospital, and rare disease medicines, supported by a Centre of Excellence in Mumbai, India.
Its portfolio includes innovative medicines, specialty generics, and biosimilars across key therapeutic areas such as hepatology, gastroenterology, infectious diseases, endocrinology, and CNS disorders. ADVANZ PHARMA fosters a culture of entrepreneurship, speed, and integrity, empowering employees to drive growth and innovation in healthcare.
About the Role:
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Specialist Regulatory Affairs LCM – Strategic Growth Products.
The main purpose of this role is to ensure timely and compliant life cycle management (LCM) activities for Marketing Authorizations (MA) held by ADVANZ PHARMA. The focus lies on maintaining supply continuity and regulatory compliance across global markets.
Education:
- Graduate or post-graduate in Science, preferably Life Sciences or Pharmacy.
- Formal training in Regulatory Affairs.
Key Responsibilities:
- Support the New Product Introduction (NPI) team in label and mock-up approvals, managing national phase procedures, and liaising with health authorities.
- Serve as the primary contact for Health Authorities post-marketing authorization.
- Collaborate with cross-functional teams—Quality, Supply Chain, Technical, Medical, and Commercial—on post-approval regulatory activities.
- Oversee renewal and variation applications, drug shortage notifications, regulatory commitments, and label updates.
- Lead LCM for assigned molecules globally, ensuring alignment with regulatory strategies.
- Participate in change control meetings and SNOP discussions for assigned molecules.
- Support new market expansion by managing regulatory submissions for EU/UK-approved products.
- Contribute to due diligence, M&A integration, and continuous improvement initiatives.
- Ensure readiness for health authority inspections and timely CAPA completion.
Skills & Experience:
- Hands-on experience in life cycle management of pharmaceuticals in EU/UK or other regulated markets (Canada, Australia, New Zealand).
- Strong knowledge of ICH Clinical and Safety guidelines, EU/UK regulatory procedures, and CTD format.
- Experience in medical writing, label expansion, and regulatory submissions.
- Proficiency in document management and change control systems.
- Excellent communication, project management, and strategic thinking skills.
- Ability to work collaboratively, adapt quickly, and thrive in a fast-paced environment.
