Maiva Pharma Private Limited (FDA Approved Sterile Injectables)
Website:
maivapharma.com
Job details:
Company Description
Maiva Pharma Private Limited, based in Hosur, Tamil Nadu, specializes in the manufacturing of high-quality sterile injectables in small volume vials, ampoules, and large volume glass bottles. With over two decades of expertise, the company provides integrated pharmaceutical development and manufacturing, from formulation development to commercial supply. Holding accreditations such as USFDA, EU-GMP, and Health Canada approvals, Maiva is recognized for its commitment to quality and compliance. Backed by advanced infrastructure, including integrated ampoule and vial lines, the company has established itself as a trusted name in the global sterile injectables market.
Role Description
This is a full-time, on-site role for a Regulatory Affairs Executive, located in Hosur. The Regulatory Affairs Executive will manage regulatory documentation, ensure compliance with regulatory requirements, prepare dossiers, and oversee global regulatory affairs. The individual will collaborate across departments to meet regulatory timelines and support the successful registration and maintenance of products in local and global markets.
Qualifications
- Knowledge of Regulatory Documentation and Dossier Preparation
- Understanding of Regulatory Requirements and Regulatory Compliance
- Experience in Regulatory Affairs processes and systems
- Strong attention to detail and ability to meet deadlines
- Effective communication and organizational skills
- Familiarity with global regulatory bodies and cGMP practices is an advantage
- Bachelor's or Master’s degree in Pharmacy, Life Sciences, or a related field
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