Website:
oxveolipharmaceuticalpvtltd.com
Job details:
Company Description Oxveoli Pharmaceutical Pvt. Ltd. is an export-focused pharmaceutical company specializing in the manufacturing and global supply of high-quality healthcare products. With over a decade of experience in the Indian market and support from a strong group of companies, Oxveoli offers Finished Dosage Forms (FDF), Active Pharmaceutical Ingredients (API), nutraceuticals, and food supplements. The company operates GMP-certified manufacturing facilities and emphasizes quality, compliance, and innovation in all processes. Oxveoli provides end-to-end solutions, including contract manufacturing, private labeling, regulatory support, and worldwide distribution. Guided by integrity and long-term partnerships, we deliver safe, effective, and affordable healthcare solutions globally.
Role Description: The Regulatory Affairs Officer is a full-time, on-site role based in Surat. This position is responsible for preparing, reviewing, and maintaining regulatory documentation for domestic and international markets, ensuring accuracy and adherence to applicable guidelines. The role involves coordinating regulatory submissions, tracking approval timelines, and communicating status updates to internal stakeholders. The officer will monitor regulatory requirements and compliance standards, support product registration activities, and assist in audits and inspections. Daily tasks also include collaborating with quality, production, and marketing teams to ensure product information and labeling meet current regulatory expectations.
Qualifications
- Strong expertise in Regulatory Affairs, including understanding of regulatory frameworks and product registration processes.
- Proficiency in Regulatory Documentation, with the ability to prepare, review, and manage dossiers and technical files.
- Knowledge of Regulatory Requirements and Regulatory Compliance applicable to pharmaceuticals, nutraceuticals, and related healthcare products.
- Experience in coordinating Regulatory Submissions for national and international regulatory bodies.
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
- Familiarity with GMP standards and quality systems in pharmaceutical manufacturing.
- Strong attention to detail, analytical skills, and ability to interpret regulatory guidelines.
- Effective written and verbal communication skills and ability to work collaboratively with cross-functional teams.
- Prior experience in regulatory affairs within the pharmaceutical or healthcare industry is preferred.
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