Regulatory Affairs Manager

Daya Teb Tehran

Posted Over a month ago

Job Description

• Preparation of registration documents for Pharmaceuticals, Hygienic Products, Food Supplements & Natural Medicines • Compile country specific re-registration and variation files • Follow-ups with the Iranian Ministry of Health on files review and ensure timely submission of additional documentation requested

Requirements

• Good knowledge about writing SOP and other related documents • Familiar with international GMP guidelines specially PIC/S • Familiar with Pharmacopeia especially USP • Proven track record in regulatory affairs with strong connection to health care authorities. • Preferably reputable with credibility in font of MOH • Ability to work in a team environment, handle multiple tasks • Being able to handle the stress of tight deadlines and a fast paced work environment • A strong knowledge of MS office programs. • Strong communication skills • Excellent documentation skills • Flexibility and adaptability • Excellent command of English

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