Regulatory Affairs Executive
1 day ago
Company Description
Olive PharmaScience Ltd, an Indian pharmaceutical manufacturer with over five decades of experience, specializes in developing and manufacturing high-quality pharmaceuticals, OTC products, and dietary supplements. Renowned for its focus on advanced soft gelatin dosage forms, the company leverages its expertise in research and development to enhance the bioavailability and therapeutic efficiency of its formulations. With two state-of-the-art, cGMP-certified manufacturing facilities in India, Olive PharmaScience Ltd serves clients worldwide with precision and excellence. The company is committed to innovation, global partnerships, and delivering cutting-edge solutions at the intersection of science and wellness.
Role Description
This is a full-time on-site role for a Senior Executive Regulatory Affairs based in Mumbai. The Senior Executive will be responsible for preparing, reviewing, and submitting regulatory dossiers and ensuring compliance with national and international regulatory requirements. Key responsibilities include compiling and reviewing technical documents, managing communication with regulatory authorities, keeping up-to-date with changes in regulations, and supporting cross-functional teams to ensure successful product registration and approval.
Qualifications
- Experience in regulatory submissions and expertise in interpreting and applying national and international regulations.
- Strong technical knowledge in pharmaceutical development, manufacturing processes, and documentation requirements.
- Excellent communication and report-writing skills for presenting regulatory findings and documentation effectively.
- Attention to detail and the ability to manage multiple regulatory projects simultaneously within deadlines.
- A Bachelor's or Master's degree in Pharmacy, Chemistry, or related field, with prior experience in regulatory affairs within the pharmaceutical industry.
- Proficiency in regulatory software tools and familiarity with global regulatory guidelines (e.g., FDA, EMA, MHRA, WHO).
- Problem-solving, collaboration, and leadership skills to work effectively with cross-functional teams and regulatory agencies.
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