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Company Description
Zazen Healthcare Pvt. Ltd., based in Vadodara, Gujarat, represents an exciting new chapter in pharmaceutical innovation, built on 27+ years of expertise in Contract Development and Manufacturing (CDMO) from Zazen Pharma Pvt. Ltd. With a state-of-the-art EU-GMP compliant facility, the company specializes in Dry Powder and Liquid Injections with provisions for advanced formats like lyophilized and pre-filled syringes (PFS). Zazen Healthcare upholds a legacy of strong values, quality, and a commitment to global standards, aiming to excel in new markets and achieve milestones in the pharmaceutical industry. The company is fueled by a passion for excellence and innovation.
Role Description
This is a full-time on-site role for a Regulatory Affairs Specialist located in Vadodara, Gujarat. The role involves preparing, reviewing, and submitting regulatory documents to ensure compliance with local and global regulatory requirements. Key responsibilities include managing regulatory submissions, staying updated on changing regulations, ensuring adherence to compliance standards, and addressing regulatory inquiries. Collaboration with cross-functional teams to support product registrations and approvals will be a vital aspect of this position.
Qualifications
- Proficiency in preparing, reviewing, and managing Regulatory Documentation and submissions for Injectable Manufacturing plant in DPI, Ampoules and Vials
- Strong understanding of Regulatory Compliance and adherence to local and international standards
- Familiarity with Regulatory Requirements and knowledge of global pharmaceutical regulations and guidelines
- Expertise in Regulatory Affairs with the ability to handle product registrations and regulatory processes efficiently
- Strong organizational and communication skills
- Bachelor’s degree in Pharmacy, Life Sciences, or a related field (Master’s degree is an advantage)
- Experience in the pharmaceutical or healthcare industry is a plus
- Exposure with Regulatory Approved plant like USFDA, EUGMP and ANVISA etc. is must.
-Salary is no bar for Right Candidate
-Interested may share their CVs at hr@zazenhealthcare.com
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