19/04/2025
We are hiring in Melano Pharma (Regulatory affairs specialist)
• Working Hours: from 8:45 AM to 5:00 PM from Sunday to Thursday
• 2 days off
• Work status : Semi indoor and outdoor.
Job Requirements:
• Gender: Females/Males
• Graduated from: Faculty of pharmacy, Science, Veterinary.
• Very Good command of English
• Good with Microsoft Office
• Residency :Cairo, giza region.
Job Responsible
Responsible for performing Regulatory Affairs activities to maintain product registrations, product licenses and relevant life cycle management activities within the defined timelines and in full compliance with the legislation and regulations.
Job description
• Preparing the registration files for the EDA for new launches, and registration renewal applications to keep licenses valid.
• Participate in and follows up of different regulatory processes required for registration of the company’s new products and maintenance of existing ones in the local and export market by ensuring timely submission of registration documents and formats as per the regulations.
• Keeping up to date with changes in regulatory legislation and guidelines and ensuring that the company strictly follows government rules and regulations.
• Preparing the registration files needs to be registered in different foreign countries in an effectively timely manner.
• Implement regulatory plans for the submission of new products and maintenance activities for existing products to meet department plans.
• Effective communication and cross-functional interaction with all involved departments, both on a Regional and Central level (Regulatory Affairs, Quality Assurance, Quality Control, Production, Supply chain, Sales and Marketing and Pharmacovigilance) to facilitate and develop effective collaboration on all regulatory interactions.
• Create regulatory procedure/Standard Operating Procedures, as necessary.
• Informs the site about the regulatory actions to perform follow ups until approval of dossier, deficiency letter or supplement/variations.
• Provides regulatory advice to assist teams and gives updates at staff meetings.
• Maintains awareness of applicable regulations and guidance to keep up to date with the relevant guidelines and information that could impact on the regulatory projects.
• Review and approve product labels and promotional materials
Company Benefits:
* Competitive salary
* Opportunities for promotions
* Good work environment
Candidates who fit the mentioned criteria are invited to apply for the position to following this email address and mentioning the job title in the email subject
Hr@melanopharma.com
Good Luck
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