Regulatory Affairs Senior Specialist

This is where you save and sustain lives

At Baxter we are deeply connected by our mission. No matter your role at Baxter your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxters products and therapies are found in almost every hospital worldwide in clinics and in the home. For over 85 years we have pioneered significant medical innovations that transform healthcare.

Together we create a place where we are happy successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining liveswhere your purpose accelerates our mission.

At Baxter Healthcare Corporation we have an exceptional opportunity for a Regulatory Affairs Senior Specialist in Algeria. As a motivated and wellspoken Regulatory Affairs (RA) Specialist you will be responsible for managing a portfolio of Pharmaceuticals and Medical devices registrations in Algeria. This includes preparing submitting following up and obtaining approval for new registrations renewals and maintenance activities. You will work closely with the Algeria Ministry of Pharmaceutical Industry to implement RA plans and ensure compliance with both Baxter standards and local health authority regulations.

Your role will be crucial in maintaining Baxters perfect reputation and ensuring worldclass RA compliance efficiently implementing global regulatory strategies and maintaining marketing authorizations for our products.

Summary

• Manage regulatory activities for a specific global portfolio of products/projects.

• Acquire and maintain marketing authorizations for Baxters products and communicate local regulatory requirements.

• Act as a consultant on projects requiring RA advice.

• Understand all aspects and phases of rolebased activities including submission processes ownership of regulatory systems and stewardship of new/changing regulations.

• Respond to complex questions from regulatory authorities within strict timelines.

• Compile and submit regulatory documents according to requirements.

• Maintain and update existing regulatory authorizations.

• Review and approve labeling SOPs and AdProm materials for compliance.

• Handle and manipulate 3rd party providers and distributors.

Requirements:

• Minimum of 2 years of regulatory or equivalent experience within the medical devices industry.

• A degree in Pharmacy.

• Indepth knowledge of regulations and scientific principles.

• Proficient English skills.

• Strong project management skills with the ability to handle multiple projects.

• Excellent prioritization abilities.

• Exceptional interpersonal and communication skills.

• Technical proficiency in word processing spreadsheets databases and online research.

• Identify compliance risks and effectively communicate concerns when needed.

Skills:

• Effective listening abilities: Display active listening skills to comprehend and address the requirements and concerns of individuals involved.

• Ability to provide regular weekly updates on progress and explain the progress effectively.

• Ability to work effectively with other teams and adjust quickly to changing circumstances.

• Selfmotivated with a high level of initiative: Proactively take ownership of tasks and drive projects forward.

If you are highreaching and seeking a chance to create a significant impact in the field of regulatory affairs we invite you to apply for this position.

Join our team and be a part of our mission of saving and sustaining lives worldwide.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.