At Baxter, our mission is more than just words—it’s the heartbeat of everything we do. Every role here, including yours, has the power to make a profound impact on millions of lives worldwide. From hospitals to clinics to homes, our products and therapies touch people in nearly every corner of the globe. For over 85 years, we’ve been at the forefront of medical innovation, transforming healthcare and improving outcomes for patients everywhere.
This is where you come in.
We’re looking for a passionate, driven, and articulate Regulatory Affairs (RA) Manager to lead our efforts in KSA (Kingdom of Saudi Arabia) for both drugs and devices. If you’re someone who thrives in a fast-paced, purpose-driven environment and has a knack for navigating complex regulatory landscapes, this role is for you.
Your Mission
As the RA Manager, you’ll be the driving force behind setting and executing regulatory strategies across KSA, ensuring compliance with local health authority regulations. You’ll be the bridge between Baxter and regulatory authorities, leveraging your strong network and deep understanding of local regulations to keep our portfolio aligned with the latest updates.
This isn’t just about compliance—it’s about making a difference. You’ll play a pivotal role in bringing life-saving products to market, ensuring they meet the highest standards of safety and efficacy.
What You’ll Do
- Develop and implement global regulatory strategies to obtain and maintain marketing authorizations for Baxter’s products.
- Act as a trusted consultant to managers, providing expert regulatory advice and guidance.
- Stay ahead of the curve by monitoring health authority updates and communicating their impact to stakeholders.
- Lead regulatory activities for a portfolio of products, ensuring all submissions are timely, accurate, and compliant.
- Collaborate with cross-functional teams to address complex regulatory challenges and drive projects forward.
- Prepare, review, and approve labeling, SOPs, and promotional materials to ensure compliance with local regulations.
- Mentor and guide junior team members, fostering a culture of growth and excellence.
What You Bring
- 5+ years of regulatory affairs experience in the pharmaceutical or medical device industry.
- A scientific degree (Bachelor’s or equivalent) and a deep understanding of regulatory requirements.
- Strong project management skills with the ability to juggle multiple priorities and deadlines.
- Exceptional communication and negotiation skills, both verbal and written.
- A proactive, self-motivated mindset with the ability to work independently and under pressure.
- Fluency in English and Arabic (non-negotiable).
- A collaborative spirit and the ability to thrive in a multicultural, multinational environment.
Non-Negotiables
- Resilience under pressure and the ability to stay calm in high-stakes situations.
- A keen eye for detail and a commitment to delivering high-quality work.
- Strong organizational skills and the ability to multitask effectively.
- A team player who can also take ownership and drive initiatives independently.
Why Baxter?
At Baxter, you’ll be part of a team that’s driven by purpose and united by a shared mission. We’re proud of our legacy, but we’re even more excited about the future. As of February 1, 2024, our Kidney Care business has transitioned to Vantive, a new entity built on nearly 70 years of excellence in acute therapies and dialysis care. This role will initially be under Baxter, with a planned transition to Vantive as the legal entity goes live.
Inclusion and Accessibility
Baxter is committed to creating an inclusive workplace. If you require reasonable accommodations during the application or interview process due to a disability or medical condition, please let us know. We’re here to support you.
Ready to Make an Impact?
If you’re ready to take on a role where your work truly matters, we’d love to hear from you. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.