Life Sciences MSc Jobs at ADVANZ PHARMA
Join ADVANZ PHARMA as a Specialist in Regulatory Affairs for Lifecycle Management (LCM) of Strategic Growth Products. This hybrid role in Mumbai offers a dynamic opportunity to drive post-approval regulatory strategies, product continuity, and compliance across global markets. Be part of a team that’s shaping the future of specialty and rare disease medicines.
Job Posting: Specialist Regulatory Affairs LCM – Strategic Growth Products at ADVANZ PHARMA
About ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.
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 Specialist Regulatory Affairs LCM Strategic Growth Products. The main purpose of this role is to ensure adequate and prompt life cycle
maintenance activities for Marketing Authorization (MA) held by ADVANZ PHARMA based on the assigned portfolio with a focus on supply continuity and compliance with regulatory requirements.What You’ll Do:
- Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization
- Become the primary point of contact for Health Authorities following grant of Marketing Authorisation
- Work closely with necessary stakeholders to execute all post approval activities
- Contribute to the preparation of meeting packages for Scientific Advice
- Support market expansion activities and maintenance of Hand over document
- Participate in continuous improvement initiatives and act as a process owner for regulatory procedures
About You
We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.
Qualifications :
- Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy
- Formal training in Regulatory
Knowledge, Skills & Experience:
- Significant experience in handling life cycle management of pharmaceuticals in regulated markets for Regulatory Affairs BSc/MSc Life Science Job
- Good understanding of ICH Clinical and Safety guidelines
- Strong Project Management and Communication skills
- Ability to work under pressure and adapt to evolving business situations
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