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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 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.
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.
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