Edkem Pharmaceuticals Ltd.
Website:
edkempharma.in
Job details:
Company Description
Edkem Pharmaceuticals Ltd., located in Gallops Industrial Park, Moraiya, near Ahmedabad, is strategically situated in a vibrant pharmaceutical ecosystem. The state-of-the-art facility complies with national and international regulatory guidelines. The plant specializes in producing a wide range of general section dosages, such as tablets, capsules, liquid orals, and external preparations like ointments, creams and lotions. Edkem Pharmaceuticals is committed to high-quality standards and innovation in pharmaceutical manufacturing.
Role Description
This is a full-time, on-site role for a Regulatory Affairs Manager based in Satellite Road, Ahmedabad. The Regulatory Affairs Manager will oversee compliance with regulatory requirements, manage regulatory submissions, maintain quality systems, and ensure adherence to national and international regulatory standards. Responsibilities also include coordinating with cross-functional teams, ensuring product documentation aligns with regulatory norms, and keeping updated on changes in regulatory landscapes.
Qualifications
- Strong knowledge of Regulatory Compliance and Regulatory Requirements
- Experience in Regulatory Affairs and Regulatory Submissions
- Understanding of Quality Systems and their application in a pharmaceutical setting
- Familiarity with CTD and ACTD dosiers
- Proven organizational and communication skills for cross-functional collaboration
- Bachelor's or Master's Degree in Pharmacy, Life Sciences, or related field
- Previous experience in regulatory affairs within the pharmaceutical industry is necessary
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