Pharma Jobs: Advanz Pharma is Hiring a Specialist in Regulatory Affairs | Apply Now for Regulatory Affairs Jobs
Are you looking for Pharma jobs, specifically want to kickstart you career in Regulatoy Affairs Job Role? Here is an exciting opportunity. ADVANZ PHARMA is seeking a Specialist in Regulatory Affairs EU for a temporary 6–8 month position in Andheri, Mumbai (hybrid working). The position offers an opportunity to work in a dynamic, global pharmaceutical environment while supporting regulatory excellence and team development.
Job Details:
- Job Title: Specialist, Regulatory Affairs EU
- Location: Andheri (East), Mumbai, India
- Employment Type: Temporary, 6–8 months
- Work Mode: Hybrid
About the Regulatory Affairs Role:
The Specialist, Regulatory Affairs EU supports lifecycle maintenance for Marketing Authorizations (MAs) with a focus on supply continuity and regulatory compliance. This role also involves integration activities, regulatory intelligence, project management, and coaching junior team members.
About ADVANZ PHARMA:
ADVANZ PHARMA is a global pharmaceutical company dedicated to improving patients’ lives through specialty, hospital, and rare disease medicines. With headquarters in London, UK, and approximately 700 employees across 20+ countries, ADVANZ partners with innovative biopharma companies to bring high-quality medicines to patients in Europe, Canada, and Australia.
The company’s product portfolio and pipeline include innovative medicines, specialty generics, biosimilars, and originator brands, covering therapeutic areas such as hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and rare diseases. ADVANZ thrives on the values of entrepreneurship, speed, and integrity, empowering a highly qualified global workforce.
Education:
- Graduate/Postgraduate in Science or Pharmacy.
Regulatory Affairs Role – Key Responsibilities:
- Manage lifecycle maintenance activities for assigned EU portfolio.
- Drive integration processes during mergers & acquisitions, including regulatory intelligence and project management.
- Review regulatory submissions, ensuring “right first time” quality and compliance.
- Build strategies for complex regulatory submissions and negotiate with health authorities as needed.
- Act as process owner for regulatory-driven cross-functional processes, promoting simplification and improvement.
- Disseminate regulatory updates, conduct training, and support legislative compliance.
- Act as delegate for Manager/Sr. Manager in cross-functional meetings and approvals.
- Support health authority inspections and coach junior team members.
Skills:
- Significant experience in regulatory affairs for EU/UK/Ireland markets, focusing on lifecycle maintenance.
- Proficiency in CTD, eCTD, ICH guidelines, and regional regulatory knowledge.
- Strong project management, communication, and cross-functional collaboration skills.
- Positive, solution-oriented, and committed to delivering high-quality outcomes.
- Adaptable, learning-agile, and able to thrive in a dynamic, inclusive environment.
