Regulatory Coordinator

**Company Description**
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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
- Prepare and manage Marketing Authorisation Applications (MAA) for Sobi products in GCC Region, including submission to Health Authorities via national or centralised procedures.
- Assess and process variations, renewals, and CMC changes for products and manufacturing sites across GCC/ME region, ensuring compliance with regulatory requirements.
- Maintain up-to-date product files and regulatory documentation, including labels and leaflets, to meet internal and external requirements.
- Monitor and report on regulatory activities, including significant changes in the regulatory environment, and prepare monthly reports.
- Optimise approval timelines by effectively managing file evaluations and liaising with Health Authorities.
- Ensure compliance with national legislation, international and local regulatory guidelines, and internal requirements whilst optimising company resources.
- Provide regulatory advice and support to internal stakeholders, ensuring quality standards are met and submissions adhere to strict deadlines.
- Perform additional Regulatory Affairs duties as requested by the manager.

**Qualifications**
Required Qualifications:

- Bachelor's degree in pharmacy
- Minimum of 2 years' experience in Regulatory Affairs within pharmaceutical companies
- Familiarity with SFDA guidelines and regulatory requirements in GCC countries
- Experience managing variations, renewals, labelling updates, and other LCM submissions
- Strong written and spoken English skills
- Ability to handle multiple projects and adapt to changing regulatory requirements
- Excellent soft skills and presentation abilities

Desired Qualifications:

- GCC and/or Middle East working experience
- Arabic language proficiency
- Knowledge of Health Authority requirements in Middle East countries

**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