Regulatory Affairs Executive at Unique Biotech Limited
Location: Hyderabad
Experience: 2-3 Years
Education: B.Pharm, M.Pharm, MSc, BSc
Salary: Not Disclosed
Application Mode: Email (nishitha@uniquebiotech.com)
Skills: Time management, Flexibility, Problem-solving, Work/Life Balance
About Unique Biotech Limited (UBL)
Unique Biotech Limited (UBL) is a global leader in biotechnology, specializing in delivering high-quality, safe, and innovative formulations. With an emphasis on regulatory compliance, UBL operates in a dynamic environment, ensuring that its products meet both local and international standards. The company provides a supportive work culture that values flexibility, time management, and problem-solving, creating an ideal setting for professionals looking to advance their careers in regulatory affairs. Regulatory Affairs Executive at Unique Biotech Limited
Job Description: Regulatory Affairs Executive
Unique Biotech Limited is seeking a Regulatory Affairs Executive with 2-3 years of experience in formulations. This role requires active involvement in preparing and submitting regulatory documentation, ensuring compliance with both local and international regulatory bodies. As a key player in the regulatory team, you will ensure the company’s products are registered in various countries, maintain compliance with ever-evolving regulations, and collaborate with multiple internal teams to streamline submissions. Regulatory Affairs Executive at Unique Biotech Limited
Key Responsibilities
- Dossier Preparation and Submission: Prepare and submit dossiers for product registrations in different countries, ensuring compliance with various regulatory standards.
- Maintain Regulatory Compliance: Stay updated with current pharmaceutical regulations and ensure the company’s formulations adhere to both local and international guidelines.
- Collaborate with Internal Teams: Work with internal departments to gather the required documentation and ensure the timely submission of regulatory documents.
- Address Regulatory Queries: Handle queries from health authorities and clients efficiently, providing clear, accurate information in a timely manner.
- Documentation Management: Ensure all regulatory documents are properly filed and maintained to meet audit and inspection requirements.
- Stay Updated on Regulations: Monitor changes in the pharmaceutical industry’s regulatory landscape to ensure that UBL remains compliant with evolving guidelines. Regulatory Affairs Executive at Unique Biotech Limited
Why This Role is Exciting
Regulatory Affairs Executive at Unique Biotech Limited
Working as a Regulatory Affairs Executive at UBL provides you with an exciting opportunity to contribute to the global expansion of a biotechnology leader. In this role, you will be at the forefront of regulatory processes, navigating the complex landscape of international regulatory frameworks and guidelines.
This position allows you to develop valuable skills in dossier preparation, compliance, and regulatory submissions while working alongside industry professionals who are equally committed to delivering high-quality pharmaceutical solutions. Your role is crucial in ensuring that UBL’s products meet regulatory standards and are available to patients around the world. With a strong emphasis on teamwork, communication, and organizational skills, this is an excellent opportunity to grow your career in regulatory affairs. Regulatory Affairs Executive at Unique Biotech Limited
Required Qualifications and Skills
- Educational Background: Bachelor’s or Master’s degree in Pharmacy, Biotechnology, or a related field (B.Pharm, M.Pharm, MSc, BSc).
- Experience: 2-3 years of experience in regulatory affairs, specifically in formulations.
- Knowledge of Regulatory Documentation: Familiarity with dossier preparation, regulatory submissions, and compliance with both local and international regulatory bodies.
- Proficiency in Regulatory Tools: Experience with regulatory software and tools for efficient submission of documents.
- Communication and Organizational Skills: Strong ability to communicate effectively with health authorities, internal teams, and clients. Exceptional organizational skills to manage multiple submissions and tasks.
- Regulatory Expertise: Understanding of pharmaceutical guidelines and international regulatory frameworks. Regulatory Affairs Executive at Unique Biotech Limited
How to Apply
If you’re passionate about regulatory affairs and have the required experience, UBL offers a dynamic environment where you can thrive. Share your updated resume with us at nishitha@uniquebiotech.com and become a part of our journey in advancing biotechnology solutions worldwide. This is your chance to grow in a forward-thinking company while ensuring that our formulations meet the highest regulatory standards. Apply today!