Regulatory Affairs Manager - KSA

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. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's 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 lives—where your purpose accelerates our mission.

We are looking for a motivated and well-spoken RA Manager leading  KSA country (drugs and devices)!

The RA lead is responsible for setting RA plans and executing them across KSA or indirectly through distributor markets.

To be successful in this role the candidate needs to comply with Baxter RA standards under the umbrella of the local health authority regulations, should have a very strong network with local RA authorities.

RA Lead should be very well-oriented with all HA updates and regulations and communicate with the relevant stakeholders the impact of any recent  updates  and make sure Baxter portfolio complies with these regulations.

Summary

• Responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products. Serves as a consultant to managers.

• Manage regulatory activities relating to specific global portfolio of products/projects.

• Responsible for the local implementation of complex global regulatory strategies

• Obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of Baxter’s products.

• Serves as a consultant to managers. Manage regulatory activities relating to specific portfolio of products/projects.

• Understands all aspects and phases of role-based activities (e.g.: the submission process across the product lifecycle continuum, including management of submission content/format to ensure high quality submissions that facilitate review/approval by Regulatory Authorities.  Ownership/Life cycle of Regulatory systems, trackers and databases.  Stewardship of Baxter position/impact of new/changing regulations, guidances and standards.)

• Initiate and develop complex regulatory project plans

• Identify & prioritize key areas of regulatory risk

• Initiate and develop role-based complex regulatory activities

• Monitor applicable regulatory requirements

• Create and maintain regulatory files in a format consistent with requirements

• Provide regulatory advice to project teams.

• Respond to complex questions from regulatory authorities within strict timelines

• Provide role-based regulatory advice to project teams.

• Coordinate responses to complex questions from cross functional areas in a timely manner

• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements

• Maintain and update existing regulatory authorizations

• Manage regulatory activities relating to specific portfolio of products/projects

• Prepare, review, and approve labeling and SOP’s. 

• Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations

• Prepare SOPs to reflect specific local requirements.

• Responsible for update and maintenance of role-based activities.

• Lead or represent Regulatory Affairs in project teams

• Provide guidance and coaching for areas of responsibility to lower level team members

Requirements

• 5 years of regulatory or equivalent experience within a pharmaceutical

• Knowledge of regulations

• Scientific knowledge

• Project management skills

• Manage multiple projects and deadlines

• Ability to multitask and prioritize

• Interpersonal and communication skills

• Strong negotiation skills

• Technical system skills (e.g. word processing, spreadsheets, databases, online research)

• Ability to work effectively in multinational/multicultural environment

• Ability to identify compliance risks and escalate when necessary

• Bachelor’s degree or country equivalent in a scientific discipline

Non-Negotiable skills

• Stress resistance

• Excellent communication skills, both verbal and written.

• Good organizational skills and the ability to multitask.

• Strong listening skills.

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

• Strong team player, with flexible approach yet able to work unsupervised and under pressure

• Self-motivated with a high level of initiative

• Excellent communication skills and be able to work in a rapid response environment

Language skills

• Fluent English and Arabic

As of February 1, Baxter has completed the sale of its Kidney Care business, which will now operate as Vantive. Today, this job is within a Vantive deferred market, which means that the employer of record for this role will initially be Baxter. When the applicable legal entity in country goes live, the employer of record for the role will transition to Vantive. Vantive builds upon on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will continue to lead in the kidney care space and offer meaningful work to those who join us. If you have any questions, please review with the recruiter and/or hiring manager.

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.

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