Are you a skilled professional in Drug Regulatory Affairs looking for an exciting career opportunity? Barrolex India Pvt. Ltd., a leading name in the pharmaceutical and healthcare industry, is currently hiring for roles in Drug Regulatory Affairs. If you have expertise in regulatory compliance, drug approvals, and dossier submissions, this could be your chance to join a dynamic team and contribute to the global healthcare landscape.
About Barrolex India Pvt. Ltd.
Barrolex India Pvt. Ltd. is a renowned organization specializing in regulatory affairs, drug approvals, and compliance with global healthcare standards. With a strong presence in the pharmaceutical sector, Barrolex is committed to ensuring the highest levels of quality and compliance in the development and marketing of drugs and medical devices.
Job Description: Drug Regulatory Affairs
As a part of the Regulatory Affairs team at Barrolex, you will play a pivotal role in ensuring compliance with national and international regulations. Here’s a detailed look at the responsibilities:
- Regulatory Strategy & Compliance: Develop and implement regulatory strategies to ensure compliance with global regulations, including CDSCO, US FDA, EMA, and MHRA.
- Drug Approval, Medical Device & Licensing: Manage the end-to-end process of drug and medical device approvals, including licensing and certifications.
- Dossier Preparation & Submission: Prepare, review, and submit regulatory dossiers for drug approvals and ensure timely submissions.
- Labeling & Packaging Compliance: Ensure that all labeling and packaging materials comply with regulatory requirements.
- Pharmacovigilance & Post-Marketing Surveillance: Monitor and report adverse drug reactions and ensure compliance with pharmacovigilance regulations.
- Global Regulatory Compliance: Stay updated with evolving regulations and ensure adherence to international standards.
Key Skills and Qualifications
- A degree in Pharmacy, Life Sciences, or a related field.
- Proven experience in Drug Regulatory Affairs, preferably in the pharmaceutical or healthcare industry.
- In-depth knowledge of regulatory guidelines from CDSCO, US FDA, EMA, and MHRA.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Attention to detail and the ability to manage multiple tasks efficiently.
Why Join Barrolex India Pvt. Ltd.?
- Career Growth: Be a part of a growing organization with opportunities for professional development.
- Global Exposure: Work on international projects and collaborate with global regulatory bodies.
- Innovative Environment: Contribute to cutting-edge pharmaceutical and healthcare solutions.
- Competitive Compensation: Enjoy a rewarding salary package and benefits.
How to Apply
If you are passionate about regulatory affairs and meet the qualifications, we invite you to apply for this exciting opportunity. Interested candidates can send their updated CVs to barrolexdelhi@gmail.com.
