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Summary

This role provides regulatory support for new product development activities and post market support for existing drug/biologic products. Responsibilities include preparing and implementing regulatory plans, supporting regulation changes and completion of regulatory deliverables. More specifically, this person is also responsible for managing local regulatory registrations with the global teams, which includes impact assessments, track registrations, initial registrations, re-registrations and notifications/registrations of changes that may impact the regulatory approvals.

Must be a team player who can work independently with speed and self-initiative. Pharmacist is an advantage. Well versed with pharmaceuticals and biologics regulatory landscape with at least 2 years of experience.

Essential Duties and Responsibilities.  This section contains a list of five to eight primary responsibilities of the work.  The incumbent will perform other duties as assigned.

• Participates in the development and implementation of the regulatory strategy for drugs
• Compilation, preparation and submission of new registration, license extensions, variations, safety updates, renewals and ensure approvals in a timely manner without being rejected by regulatory agency.
• Assembles regulatory file / technical dossier.
• Conducts regulatory monitoring of approved products by ensuring maintained files are current, ensuring regulatory compliance, evaluates the effects of an amendment or change and takes appropriate regulatory actions
• Able to develop and implement appropriate regulatory strategy for the country to ensure business optimization
• Monitor, track and provide project updates.
• To liaise with Global Regulatory team in obtaining materials for regulatory submission purposes, product related query from business and to address questions and issues which arise as part of registration.
• Communicate and if necessary negotiate with country Regulatory Agency (NPRA and MDA) to support key submissions/projects.
• Monitor new regulations, pro-active in sense the policy direction of the regulatory local agency and develop strategies to comply.
• Participate and maintain working relationship and to provide regulatory intelligence to relevant functional and business unit's team member.
• Able to deliver with tight deadline when needed.
• Perform other duties as assigned.

Education and/or Experience. Include the education and /or experience that is necessary to perform the job satisfactorily

• B-Pharm or B.Sc in Pharmacy.
• Fluent in English and Bahasa Melayu.
• Well-versed with new registration, license extensions, variations and renewals. Experience with medical device registration is an advantage
• 2-5 years of relevant experience in pharmaceutical and biologics regulation.

Qualifications.  .

• Knowledge of applicable regulatory laws and acts and well-versed with changing scope and evolving regulations
• Ability to communicate effectively, negotiate and persuade.
• Ability to multi-task effectively in fast-paced environment.
• Ability to keep tight deadlines and work under pressure.
• Flexibility and ability to adapt to change.
• Sound judgement in applying regulatory requirements.
• Strategic thinking as well as analytical and synthesis skills.
• Highly organized, detail oriented and efficient
• Team player who seeks to help and learn from colleagues seeing the department success as their own.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
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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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.