Website:
moribuspharma.com
Job details:
Company Description
Moribus Pharma, part of the Medjisco Group, is dedicated to advancing global health through innovative science and collaboration. Specializing in medical, cosmetic, and food supplement products, Moribus Pharma leverages cutting-edge technology and research to develop high-quality, effective solutions. The company is committed to meeting the needs of diverse markets while maintaining exceptional standards for quality and customer service. At Moribus Pharma, we emphasize delivering a seamless and meaningful experience for our customers at every touchpoint.
Role Description
This is a full-time on-site role for a Senior Regulatory Affairs Specialist based in Surat. The role involves preparing, reviewing, and maintaining regulatory documentation, ensuring compliance with local and international regulatory requirements, and managing regulatory submissions. The individual will work closely with cross-functional teams to ensure products meet stringent guidelines and standards while supporting regulatory strategies to facilitate product approvals. Collaboration with different regulatory bodies and staying updated on evolving industry regulations are key aspects of this role.
Qualifications
- Proficiency in Regulatory Documentation, including the preparation and review of technical files and reports.
- Understanding of Regulatory Compliance and the ability to ensure adherence to local and international standards.
- Strong knowledge of Regulatory Requirements and expertise in applying them to various product categories.
- Experience in Regulatory Affairs, including product classification, registrations, and consultation with regulatory authorities.
- Skills in preparing and managing Regulatory Submissions, such as dossiers and approvals for new and existing products.
- Bachelor's degree in pharmacy, life sciences, or a related field; advanced degrees preferred.
- Strong analytical, organizational, and communication skills, with attention to detail.
- Experience working in a regulated industry, with familiarity in pharmaceuticals, cosmetics, or food supplements being an advantage.
- Ability to work collaboratively in cross-functional teams and effectively manage deadlines.
- At least 3-5 years of experience in Pharmaceutical Dossier preparation and submission filing.
- Ability to consult changes in art-works and confirmations as per market needs and requirements.
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