(Sr) RA Specialist at Baxter International

Taipei City, Taipei City, Taiwan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Medical DevicesIndustries

Requirements

Expert knowledge of drug regulations
Good communication and problem-solving skills
Excellent time management and project management skills
Ability to collaborate with cross-functions
Pharmacists are preferred

Responsibilities

Coordinate with GRA and BU to implement regulatory strategies for product development and commercialization
Prepare and submit all necessary regulatory documents, such as New Drug Applications (NDA), Plant Master File (PMF), Drug Master File (DMF), Post-marketing activities (License Renewal, Variations) and other submissions to regulatory authorities
Ensure ongoing compliance with global regulatory standards, including those set by the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Taiwan FDA
Act as a primary point of contact with regulatory agencies, responding to their inquiries and providing requested information
Work closely with R&D, QA, PV, manufacturing, BU and marketing teams to ensure regulatory considerations are integrated into all stages of product development
Assess and approve product labeling, packaging, and advertising materials to ensure compliance with regulations and accurate scientific claims
Delivery of regulatory documents/deliverables/packages in support of Baxter’s products/projects
Development/maintenance of Regulatory systems, trackers and databases
Evaluation and dissemination of new/changing regulations, guidance and standards

Skills

Regulatory Affairs

Drugs Registration

NDA

DMF

PMF

License Renewal

Variations

FDA

EMA

Taiwan FDA

Regulatory Strategy

Compliance

Document Preparation

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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