Regulatory Affairs Officer

About Us

Besins Healthcare is a global, family-owned pharmaceutical company specializing in the development and manufacturing of medical-grade hormones, with deep expertise in the following areas: gynaecology, fertility, obstetrics, endocrinology, and hormone deficiency treatments.

We are fully dedicated to advancing reproductive hormone therapies that support the lifelong health and well-being of women and men.

With a strong presence in over 90 countries, supported by 1,500 passionate employees, 22 subsidiaries, and 5 cutting-edge production sites, our continued growth is fueled by innovation, expanding current products into new territories, and partnering for distribution.

Job Purpose:

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.

Key Responsibilities:

• Acts as responsible Regulatory Team member for assigned regulatory projects.
• Preparation and submit Life-Cycle Maintenance regulatory submissions for Africa (English and French Speaking).
• Prepares and/or reviews regulatory documentation for 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/guidelines in compliance with current legislation.
• Any other duties as assigned by your manager.
• Learn, develop, and train.

Requirements:

Technical Skills/ Experience

• >4-5 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Africa, Middle East, Asia (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)-Europe/Turkey experience is and advantage.
• Preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations.
• Experience of GCC markets/ICH guidelines/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.
• Project management experience - an advantage.
• Experience of Women’s and/or Men’s healthcare – an advantage

Soft Skills

• Ability to work to tight timelines and manage peaks in workload.
• Good team player with internationally based colleagues in Global Pharmaceutical Affairs team.
• Positive can-do attitude in growing company with expanding range of therapeutic product range.
• Good negotiating skills and the ability to identify and resolve issues with external stakeholders.
• Excellent verbal and written communication skills.
• Excellent computer skills e.g. Word, Excel, data and document management systems.
• Cultural awareness for global ways of working.
• Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate.
• Desire to grow regulatory operational and regulatory strategy experience.
• Languages: Speaking & Writing “French “is a Must- Fluent Arabic/English Required as well.

Minimum required education and experience

• Degree in Pharmacy or life science-related degree plus at least 4-5 year’s relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Middle East/ Africa/Asia

Interested? Please apply and join us!