Sr Specialist, Regulatory Affairs

서울시
정규직
풀타임

11일 전

This is where your work makes a difference.At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.Here, you will find more than just a job—you will find purpose and pride.Summary:Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for pharmaceutical products and the preparation of documents/packages for regulatory submissions and keep registration records in applicable RA systems.Essential Duties and Responsibilities:

Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations aligned with business strategy.
Establish appropriate communication within RA and other functions primarily at project level
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
Review promotional material and SOPs for compliance with local and global regulations
Review, edit and proofread, track status and progress regulatory documentation
Local label content management as per the regulatory requirements following internal SOPs.
Participate as an active team member of regional project teams as required

Qualifications:

Sound basis of Regulatory and scientific knowledge
Ability to manage complex projects and timelines in a matrix team environment
Strong oral and written communication and presentation skills
Ability to identify compliance risks and escalate when necessary Demonstrated interpersonal skills including strong negotiation skills
Proficiency in English

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

Bachelor’s degree or more in pharmacy with a minimum of 8 years regulatory experience with a pharmaceutical company, CRO, or similar organization. Higher degree/PhD will be an advantage.

Equal Employment OpportunityBaxter 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.Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

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