Rusan Pharma Ltd., a leading global pharmaceutical company based in Mumbai, India, is currently seeking qualified candidates for the position of Officer/Executive in API Regulatory Affairs. This is a full-time, on-site role that presents a valuable opportunity for individuals looking to advance their career in the pharmaceutical industry. With a strong commitment to addiction and pain management, Rusan Pharma has been at the forefront of opioid substitution treatment in India since 1994. Their dedication to quality, integrity, and research makes them an excellent workplace for ambitious professionals.
Company Overview
Rusan Pharma Ltd. specializes in providing a comprehensive range of products aimed at addiction treatment and pain management. With a focus on international markets, the company has established itself as a trusted name in the pharmaceutical sector, delivering high-quality healthcare solutions globally. The organization prides itself on its core values:
- Quality Focus: Ensuring the highest standards in product development and customer service.
- Research Orientation: Innovating and investing in new technologies and products.
- Respect for People: Fostering teamwork and supporting employee growth.
- Integrity: Upholding ethical standards in all operations.
Job Description
In this role, the Officer/Executive in API Regulatory Affairs will be responsible for various critical tasks related to the regulatory compliance of active pharmaceutical ingredients. The selected candidate will engage in the preparation, review, and submission of essential regulatory documents necessary for the API registration process in different global markets, including the U.S., EU, Canada, and the Rest of the World (ROW).
Key Responsibilities
The primary responsibilities for this position include:
- Preparation of Regulatory Documents:
- Develop and prepare Drug Master Files (DMFs) and other regulatory documents.
- Ensure all submissions meet the requirements of health authorities across various regions.
- Regulatory Response Management:
- Respond effectively to regulatory queries, including Deficiency Letters, Clarifications, and Requests for Information (RFIs).
- Maintain a record of communication with health authorities and ensure timely responses to inquiries.
- Cross-Departmental Liaison:
- Collaborate with Research and Development (R&D), Quality Assurance (QA), Quality Control (QC), and manufacturing teams for data collection and regulatory documentation.
- Work closely with internal departments to ensure compliance with all regulatory standards.
- Customer Coordination:
- Serve as a point of contact for international customers seeking regulatory support.
- Assist in navigating submission requirements and obtaining necessary approvals.
Qualifications
To be considered for this exciting opportunity, candidates should possess the following qualifications:
- Educational Background: M.Sc. or M.Pharm degree is mandatory.
- Experience: 1 to 3 years of relevant experience in the pharmaceutical industry, specifically in regulatory affairs for active pharmaceutical ingredients.
- Skills:
- Strong understanding of regulatory guidelines governing API registration in various global markets.
- Excellent communication skills for effective interaction with teams and health authorities.
- Analytical skills to address regulatory queries and compliance issues.
How to Apply
If you are an aspiring candidate interested in advancing your career in regulatory affairs within the pharmaceutical industry, we encourage you to apply. Interested candidates can send their resumes to corporatehr@rusanpharma.com, with the subject line “Application for Officer/Executive – API Regulatory Affairs.” Additionally, a copy of your resume should be sent to niileshvthakkar@rusanpharma.com to ensure your application is processed efficiently.
Conclusion
Joining Rusan Pharma Ltd. as an Officer/Executive in API Regulatory Affairs opens up a world of possibilities for professional growth and development. With their commitment to quality, research, and ethical standards, you will be part of a dynamic team dedicated to improving global healthcare. Don’t miss the opportunity to contribute to meaningful projects in the pharmaceutical industry by applying today!
