Hetero is a renowned pharmaceutical company committed to delivering high-quality medicines worldwide. With a strong presence in multiple markets including the Rest of the World (ROW), European Union (EU), and United States (US), Hetero focuses on innovation, compliance, and excellence in pharmaceutical formulation and manufacturing. The company fosters a dynamic work environment that encourages growth and professional development.
Job Description: Regulatory Affairs Specialist
As a Regulatory Affairs Specialist at Hetero, you will play a crucial role in ensuring regulatory compliance and facilitating the approval of pharmaceutical products across various markets. Your key responsibilities will include:
- Preparation, review, and submission of regulatory dossiers for marketing authorization.
- Managing Life Cycle Management (LCM) activities to maintain product registrations.
- Handling both post-approval and pre-approval regulatory processes.
- Demonstrating strong knowledge of Marketing Authorization Application (MAA) procedures.
- Experience in Chemistry, Manufacturing, and Controls (CMC) documentation and submissions.
Required Experience and Qualifications
- Experience: 3 to 9 years in regulatory affairs within pharmaceutical formulation.
- Qualification: M Pharma, B Pharma, or M Sc in relevant fields.
- Proven expertise in dossier preparation and regulatory submissions.
- Familiarity with global regulatory requirements, especially for ROW, EU, and US markets.
Why Join Hetero?
- Work with a global leader in pharmaceutical manufacturing.
- Opportunity to grow your career in regulatory affairs.
- Exposure to international regulatory frameworks and diverse markets.
- Collaborative and innovative work culture.
How to Apply
Interested candidates who meet the above criteria are invited to send their updated CVs to chandrasekhar.r@hetero.com. Please mention the subject line as “Application for RA” to ensure your application is processed promptly.
