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Regulatory Affairs Jobs – Azurity Pharmaceuticals
Azurity Pharmaceuticals is hiring for Regulatory Affairs Job in Hyderabad. These Biological Science Jobs offers an exciting opportunity to contribute to global regulatory submissions and lifecycle management for innovative therapies that serve underserved patient populations. Join a company dedicated to quality, inclusion, and advancing healthcare through science.
Senior Associate Job Description:
- Position: Senior Associate, Regulatory Affairs
- Location: Hyderabad, India
Senior Associate Role Summary:
The candidate getting hired for Senior Associate, Regulatory Affairs Job will support EU and International regulatory activities for assigned projects. The role involves preparing and coordinating regulatory filings for medicinal products via EU centralized and MRP/DCP procedures—including MAAs, variations, and lifecycle maintenance submissions—while maintaining effective communication with EMA and other health authorities.
Company Overview:
Azurity Pharmaceuticals is a privately held specialty pharmaceutical company dedicated to creating innovative, high-quality products that address unmet patient needs. As a leader in accessible medications, Azurity leverages integrated capabilities and a vast partner network to deliver excellence across cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan drug markets. Millions of patients have benefited from its patient-centric portfolio and robust pipeline.
Azurity prides itself on being an inclusive workplace and an Equal Opportunity Employer. Its success stems from a talented, dedicated team driven by integrity, innovation, and commitment to improving patient lives.
Principal Responsibilities of Senior Associate:
- Prepare and coordinate regulatory documentation for Regulatory Affairs & Scientific Advice procedures, Response to Questions, and Pediatric Implementation Plan submissions in Europe.
- Support change control assessments for EU and International markets.
- Periodically review product information (SPC, PIL, and Labelling) to ensure compliance with Core Safety Information (CSI) and EU standards.
- Support artwork preparation and approval for packaging materials per design and legislation requirements.
- Coordinate with internal teams and external vendors to ensure timely implementation of regulatory changes.
- Contribute to the generation and review of SOPs and work instructions.
- Monitor evolving regulatory guidelines and provide proactive input to cross-functional teams.
Qualifications & Education Requirements for Senior Associate:
- Bachelor’s degree in Biological Sciences or a related discipline.
- Minimum of 3 years’ experience in Regulatory Affairs with European or UK exposure.
- Experience with EMA and national competent authorities (NCAs).
- Background in pre-marketing activities and MAA preparation.
- Exposure to Chinese regulatory systems is a plus.
- Strong communication, analytical, and problem-solving skills.
- Ability to work effectively under pressure with limited resources.
- Excellent command of written and spoken English.
Why Join Azurity Pharmaceuticals?
At Azurity, you’ll be part of a company that transforms science into accessible solutions for patients worldwide. Biological Science Jobs offers the opportunities to expand your global regulatory expertise while contributing to impactful healthcare advancements.
How to Apply for Senior Associate Role?
Interested candidates who meet the eligibility criteria can apply directly through the Azurity Pharmaceuticals Careers Page at www.azurity.com.
Navigate to the Careers section, search for “Senior Associate, Regulatory Affairs – Hyderabad”, and submit your updated resume along with a cover letter highlighting your relevant regulatory experience and expertise.
