Regulatory Affairs Associate Manager – GCC

About Sobi

At Sobi, we believe that every individual brings unique strengths to our team, and we are committed to fostering an inclusive environment where diversity is celebrated. While we recognize that candidates may not meet every qualification listed in a job description, we encourage you to apply if you feel inspired by our mission. Together, we strive to develop and deliver innovative therapies that transform the lives of individuals living with rare diseases. Our success is driven by the dedication of our team members and our unwavering commitment to patient care.

Why This Role Matters

As a Regulatory Affairs Associate Manager – GCC, you will play a pivotal role in ensuring that life-saving treatments reach patients across the Gulf Cooperation Council (GCC) region. Your expertise will be instrumental in navigating complex regulatory landscapes, securing timely product approvals, and maintaining compliance with local health authority requirements. This position offers a unique opportunity to contribute to our mission of improving the lives of those affected by ultra-rare diseases while working in a collaborative and dynamic environment.

Key Responsibilities

• Regulatory Strategy and Planning: Develop and execute regulatory submission plans aligned with business priorities and product launch timelines across Saudi Arabia, the UAE, Kuwait, Qatar, Oman, and Bahrain.
• Submission Management: Oversee the preparation, review, dispatch, and submission of regulatory dossiers in CTD/eCTD or country-specific formats, ensuring adherence to local regulatory requirements.
• Health Authority Engagement: Serve as the primary regulatory liaison with local agents and health authorities, managing end-to-end submission activities and follow-ups to secure timely approvals.
• Compliance and Lifecycle Management: Monitor and communicate evolving regulatory requirements, assess their impact on ongoing and planned submissions, and ensure compliance with post-approval obligations.
• Cross-Functional Collaboration: Partner with Global/Regional Regulatory Affairs, Medical, Pharmacovigilance (PV), Quality, Supply Chain, Commercial, Finance, and Labelling teams to support product registration and lifecycle activities.
• Labelling and Documentation: Support the implementation and maintenance of local product information and labelling in compliance with GCC regulatory standards.
• Reporting and Stakeholder Communication: Prepare regulatory status updates, presentations, and reports for internal stakeholders and management to ensure transparency and alignment with business objectives.
• Project Leadership: Lead or support additional regulatory affairs projects and initiatives as assigned, driving continuous improvement in processes and outcomes.

Qualifications and Skills

• Bachelor’s degree in Pharmacy, Life Sciences, or a related scientific field.
• 5–7 years of experience in pharmaceutical regulatory affairs, with a strong focus on GCC markets.
• In-depth knowledge of regulatory requirements and submission processes in Saudi Arabia, the UAE, Kuwait, Qatar, Oman, and Bahrain.
• Proven experience in managing product registrations and lifecycle activities for innovative and/or specialty products is highly desirable.
• Exceptional organizational, communication, and project management skills, with the ability to prioritize tasks effectively in a fast-paced environment.
• Fluency in English and Arabic, with strong written and verbal communication abilities.

Why Join Sobi?

At Sobi, we are more than a global biopharmaceutical company—we are a team of dedicated professionals committed to making a tangible difference in the lives of patients. Our core values—Care, Ambition, Urgency, Ownership, and Partnership—guide every decision we make and every action we take. As part of our team, you will benefit from:

• A competitive compensation package that reflects your contributions.
• A strong emphasis on work-life balance, ensuring you can thrive both professionally and personally.
• A collaborative and team-oriented culture where your voice is heard and your ideas are valued.
• Ample opportunities for professional growth and development, supported by a global organization with over 1,700 employees across more than 30 countries.
• The chance to be part of a mission-driven organization that empowers you to make a meaningful impact on the lives of those living with rare diseases.

If you are ready to join a culture that empowers every person to be the difference-maker for rare disease patients, we invite you to apply. Together, we can achieve extraordinary outcomes for our patients and our communities.