Regulatory Affairs Associate Manager – GCC

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

The Associate Manager, Regulatory Affairs – GCC is responsible for managing regulatory activities across Saudi Arabia, the UAE, Kuwait, Qatar, Oman, and Bahrain to ensure timely product registrations, lifecycle maintenance, and compliance with local health authority requirements. The role supports the execution of regional business objectives through effective regulatory planning, submission management, and cross-functional collaboration with internal teams and external agents.

Key Responsibilities

• Manage regulatory activities for new registrations, renewals, variations, and other post-approval submissions across GCC markets.
• Set and execute regulatory submission plans aligned with business priorities and product launch timelines.
• Coordinate the preparation, review, dispatch, and submission of regulatory dossiers in CTD/eCTD or country-specific formats.
• Lead end-to-end submission activities and follow-up with health authorities (through the agents) to ensure timely approvals.
• Serve as the main regulatory contact for local agents and support communications with health authorities.
• Coordinate responses to health authority questions, deficiency letters, and regulatory commitments with relevant internal functions.
• Monitor and communicate new regulatory requirements and assess their impact on ongoing and planned submissions.
• Collaborate closely with Global/Regional Regulatory Affairs, Medical, PV, Quality, Supply Chain, Commercial, Finance, and Labelling teams to support product registration and lifecycle activities.
• Support implementation and maintenance of local product information and labelling in compliance with local requirements.
• Prepare regulatory status updates, presentations, and reports for internal stakeholders and management.
• Lead or support additional RA projects and initiatives as assigned.

Qualifications

• Bachelor’s degree in pharmacy, Life Sciences, or a related scientific field.
• 5–7 years of experience in pharmaceutical regulatory affairs, within GCC markets.
• Strong knowledge of regulatory requirements and submission processes in Saudi Arabia, the UAE, Kuwait, Qatar, Oman, and Bahrain.
• Experience in managing product registrations and lifecycle activities for innovative and/or specialty products is preferred.
• Strong organizational, communication, and project management skills.
• Ability to manage multiple priorities and work effectively with cross-functional teams.
• Fluency in English and Arabic.

Additional Information

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to [email protected].