Join Azurity Pharmaceuticals – Senior Associate, Regulatory Affairs Job in Hyderabad |Apply Now
Looking to grow your career in Regulatory Affairs jobs or explore exciting Pharmaceutical jobs in a thriving hub like Hyderabad? Join Azurity Pharmaceuticals, a leading specialty pharma company dedicated to delivering innovative treatments for underserved patients. Explore Regulatory Affairs jobs opportunities as a Senior Associate, Regulatory Affairs, where you’ll contribute to international compliance and quality excellence while advancing your expertise in Pharma jobs Hyderabad. This is your opportunity to make an impact with a company that values innovation, precision, and patient care.
- Job Position: Senior Associate, Regulatory Affairs
- Location: Hyderabad, India
About the Company
Azurity Pharmaceuticals is a privately held specialty pharmaceutical company known for its innovative and patient-centric approach. The company delivers high-quality, accessible medications that serve the cardiovascular, neurology, endocrinology, gastrointestinal, institutional, and orphan markets, improving millions of lives. Leveraging deep industry expertise and an expansive partner network, Azurity continues to grow its commercial product portfolio and late-stage pipeline. As an Equal Opportunity Employer, Azurity fosters a diverse and inclusive work environment-an ideal place for professionals looking for pharma jobs in Hyderabad.
Job Description: Regulatory Affairs Jobs
The Senior Associate, Regulatory Affairs will play a key role in supporting EU and International regulatory activities for assigned projects. This position involves preparing and coordinating regulatory filings for medicinal products via EU centralized, MRP, and DCP procedures, including MAAs, variations, MATs, and lifecycle maintenance submissions. You’ll engage with EMA/NCA officials and Product Leads to ensure timely approvals and compliance across territories, making it a central role for those interested in the broad realm of Regulatory Affairs jobs.
Key Responsibilities in Regulatory Affairs
- Prepare and coordinate regulatory documentation for Regulatory Affairs and Scientific Advice procedures in the EU.
- Support change control assessments and maintain compliance with European and international standards.
- Review SPC, PIL, and labeling documents for accuracy and alignment with Core Safety Information (CSI).
- Manage artwork preparation and approval processes for packaging components per legislation requirements.
- Communicate with internal and external stakeholders to ensure on-time implementation.
- Contribute to the development and review of SOPs and work instructions.
- Stay updated with evolving regulatory requirements and guide cross-functional teams in Regulatory Affairs jobs.
Qualifications and Education Requirements
- Bachelor’s degree in Biological Sciences or a related field.
- Minimum of 3 years of experience in Regulatory Affairs with European or UK exposure.
- Experience with China regulatory affairs is a plus.
- Proven track record with EMA and NCA processes.
- Background in pre-marketing activities and MAA preparation.
- Strong English communication, analytical, and problem-solving skills.
- Ability to deliver under pressure and manage multiple projects efficiently.
