Country RA Lead

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build 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 not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Summary:

• Responsible and accountable for all aspects of Regulatory Affairs in the country of operations.
• Manage regulatory activities relating to specific portfolio of products/projects to ensure full compliance of registered/marketed Baxter products.
• Work with team in the design and definition of the Regulatory strategy for the products.
• Represent Baxter in local government, industry associations, and working groups discussions to ensure positive outcomes for the company.
• Act as Qualified Person responsible for Pharmacovigilance

Essential Duties and Responsibilities:

• Initiate and develop complex regulatory project plan

• Monitor applicable regulatory requirements; Identify & prioritize key areas of regulatory risk

• Create and maintain regulatory files in a format consistent with requirements for registration activities; or activities supporting commercial operations

• Provide regulatory advice to commercial, functional, and project teams.

• Respond to complex questions from regulatory authorities within strict timelines

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

• Maintain and update existing regulatory authorizations

• Manage distributor RA to ensure on time submissions, strategy execution and compliance

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

• Prepare SOPs to reflect specific local requirements.

• Lead or represent Regulatory Affairs in project teams.

• Act as the Local Qualified Person Responsible for Pharmacovigilance as defined in local regulation.

• Oversight of all pharmacovigilance activities, safety profiles and emerging safety issues, as per applicable local legislation in the territory.

• Implement and ensure compliance to Baxter Pharmacovigilance (PV) system for medicinal products and biologics in Philippines, in compliance with the local national regulations/ standards; Global PV legislation/ standards; and Baxter policies/ procedures at a local, regional and global level.

• Have a regular management oversight meetings with the Local Pharmacovigilance Officer (LPV) for Philippines to ensure smoot case intake in PV database, case processing, regulatory submission, SDEA/ MRP/ PSP management, PSMF updates and training for local site.

• Act as point of contact for inspections from Philippines FDA; for monitoring and responding promptly to requests from Philippines FDA.

• Perform appropriate Safety Risk Management activities in Philippines in order to assure oversight of medicinal product safety and to ensure that appropriate action be taken when necessary, e.g., implementation of risk management activities.

• Perform other duties as assigned.

Work Knowledge/Skills required.

• Knowledge of PFDA 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.

Education and/or Experience:

• Degree in Pharmacy
• Minimum of 4 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization
• Knowledge in Biologics and Philippine Drug Enforcement Agency (PDEA) registration a plus factor
• Must be a Licensed Pharmacist

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

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