Lead regulatory strategy and compliance for pharmaceutical products across designated countries, ensuring alignment with both local health authorities and international standards such as those set by the EMA. This home-based position plays a central role in advancing regulatory submissions, including renewals, variations, new applications, and marketing authorization holder transfers, guiding them through approval processes with precision and expertise.
Key Responsibilities
- Coordinate and finalize regulatory submissions in partnership with internal teams and external stakeholders, following established global strategies
- Prepare and maintain country-specific product labeling documents, such as Summary of Product Characteristics and Patient Information Leaflets, in local languages including Arabic
- Review and approve packaging artwork within client platforms, ensuring regulatory accuracy and compliance
- Serve as a regulatory subject matter expert, particularly in areas such as Chemistry, Manufacturing and Controls (CMC), labeling, marketing authorization transfers, and lifecycle management
- Lead regulatory components of complex projects, including authoring submissions and completing application forms
- Support budget planning and oversight for regulatory initiatives
- Mentor junior team members through document reviews, feedback, and training support
- Contribute to the development and review of regulatory standard operating procedures
- Deliver internal training sessions on regulatory topics when needed
- Engage directly with clients to clarify regulatory requirements, address feedback, and present insights from recent submissions
Qualifications
- Master’s degree in life sciences or a related field
- Minimum of 8–10 years of experience in regulatory affairs within the pharmaceutical industry
- Proven experience preparing variations, renewals, and managing artwork approval processes
- Strong understanding of marketing authorization maintenance and global regulatory pathways
- Fluency in English and Arabic, with the ability to communicate complex regulatory concepts clearly to diverse audiences
- Excellent organizational, interpersonal, and communication skills
- Ability to thrive in fast-paced, evolving environments and lead regulatory strategy across multiple products
- Demonstrated leadership in cross-functional collaboration and client-facing engagements
