Regulatory Affairs Officer

We are a pioneering, family-run pharmaceutical company with a laser focus on the development and commercialisation of reproductive hormone treatments for the lifelong well-being of men and women. Our products are used in the fields of gynaecology, fertility, obstetrics, and endocrinology. We distribute to over 90 countries through our own subsidiaries and network of distributors. With approximately 1,300 employees worldwide, 22 subsidiaries and 5 production sites, we continue to grow – something we can only do through recruiting exceptional employees and nurturing an environment where they can thrive.

Description

Join our growing Global Regulatory Affairs team located in Dubai to prepare, contribute to and manage International MAAs and Lifecycle activities for our current and actively growing range of pharmaceutical products, therapeutic indications and international markets.

Your mission:

• Acts as responsible Regulatory Team member for assigned regulatory projects.
• Preparation and submit Life-Cycle Maintenance regulatory submissions for Africa, Middle East, Asia Pacific, Canada
• Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.
• May support on some R&D regulatory projects.
• Actively participates and employs effective communication practices with internal stakeholder (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, and Globally based Regional Regulatory affairs team)
• Understands the Scope of Work, timelines and deliverables for a given project.
• Prepare status reports and metrics for assigned projects.
• Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
• Any other duties as assigned by your Manager.
• Learn, develop, and train.

Job Requirements:

• 4-5 years of pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Africa/ Middle East/Asia/Canada (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions).
• Preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations.
• Experience of GCC markets /ICH and MHRA guidelines
• Experience of emerging markets / international RoW markets and regulatory filings.
• Quality control review of technical/ regulatory documents.
• Understanding of Regulatory strategy and determination of documentation requirements. Compliance with SOPs, Change controls and regulatory best practices.
• Publishing: eCTD and or NEES.
• Pharmaceutical artwork review and sign-off.
• English, and French language skills are compulsory
• Project management experience - an advantage.
• Experience of Women’s and/or Men’s healthcare – an advantage.

Interested? Please apply!