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Summary

Supports new product development and lifecycle maintenance activities for projects and products that are manufactured at the facility: Baxter Lessines.

Representing on-site Global regulatory function focusing on the following areas:

• Coordinating the Regulatory Affairs change control RA Pre-Assessment process in liaison with plant Quality, Manufacturing functions, and Global RA functions.

• Providing on-site regulatory support for audits/inspections related to Establishment licensing, Site GMP Certificates and/or regional submissions, and regulatory compliance of the plant with drug products and medical devices national and international normative.

• Providing Regulatory input into Site APQR (Annual Product Quality Review) across product segments.

• Provide overall Regulatory Affairs Leadership support to these manufacturing sites.

Essential Duties & Responsibilities

Provide facility Regulatory Support in the following areas:

• Provide strategic regulatory support to the manufacturing facility of pharmaceuticals and medical devices.

• Support new Regulatory requirements implementation at the facility.

• Preliminary Regulatory assessment of product changes before change control initiation.

• New product regulatory implementation at the plant.

• Provide Product Portfolio Management visibility and share requirements in all target Countries’ information to the site.

• Site audit RA support (related to requirements in all target Countries).

• Contribute to CAPA/NCR boards regulatory-related projects.

• Member of the Change Control Review Board. Change Control liaison between the plant and GRAs (GRLs and LRAs) when needed.

• Collect and send GMP/QSR-related documents for GRA to renew the Certification of international Authorities. Support Local RA with GMP document requests.

• Review and support the preparation of facility-related documents (CTD sections, STED supporting documents) to send to GRA for regulatory submissions.

• Site submission expert for responses to regulatory authority requests during regulatory filing reviews and on-site related CAPAs.

• Prepare, maintain, and update Site Master File regulatory sections upon request.

• Plant Quality Management Review participation: inform the plant about impactful new/change country regulations, requirements, and compliance projects ongoing.

• Provide ad-hoc Regulatory Awareness training to the plant Quality and Manufacturing personnel.

• RA Support to validation type of activities: for example, verify if requirements in all target Countries are met.

• Interface with GRAs and key partners at Segment, R&D, and plant leadership.

• Alignment with the expectations of Regulatory Agencies, to maintain compliance and proper implementation of local and regional regulatory requirements.

• Providing Regulatory input into Site APQR (Annual Product Quality Review) Governance across product segments. Ensuring compliance with the agenda and ensuring compliance with local, regional, and corporate requirements.​

Qualifications

• Bachelor’s degree or country equivalent in a related scientific discipline with a minimum of 10 years of experience in RA or QA, including managing people or projects. 

• Sound basis of Regulatory knowledge.

• Manufacturing and quality process understanding.

• Scientific Knowledge (international Medical Device & Drugs regulations and international standards).

• Ability to manage complex projects and timelines in a matrix team environment.

• Strong oral and written communication and presentation skills.

• Demonstrated interpersonal skills including strong negotiation skills.

• Ability to independently identify compliance risks and escalate when necessary.

• Ability to lead regulatory projects at the plant level.

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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