Regulatory Affairs lead (assistant manager)Baxter

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.
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 & Responsibilities
Initiate and develop complex regulatory project plans
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.
Conduct regular management oversight meetings with the Local Pharmacovigilance Officer (LPSO) 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
Qualifications
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 & Experience
Must be a Licensed Pharmacist
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
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [Protected Info] and let us know the nature of your request along with your contact information.
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Baxter

Calamba City, Laguna
Permanent
Full-time