Regulatory Specialist
2 weeks ago
Improve Patient Lives with Baxter
We are on a journey to revolutionize kidney care and other vital organ support. Vantive, a new company built on our legacy, will provide best-in-class care to the people we serve.
Key Responsibilities:
- Provide regulatory support for on-market products, including change assessment, variation planning, and submission documentation.
- Review and provide regulatory impact assessments for changes.
- Support global submission deliverables for product variation submissions.
- Work with the regulatory organization to achieve desired results.
- Execute global plans and regulatory submission deliverables for sustaining variations.
- Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results.
- Ensure identified standards and content requirements are met for regulatory submissions.
- Timely support query responses.
Requirements:
- Bachelor's Degree or country equivalent in a related scientific discipline.
- Higher degree/PhD will be an advantage.
- Sr. Associate - Minimum of 6 years' regulatory experience in RA or related healthcare environment.
- Experience operating in a regulated environment.
- Ability to operate in a matrixed environment and manage multiple activities, priorities, and deadlines.
- Exercise independent judgement.
- Scientific knowledge and ability to discuss technical matters with cross-functional team members.
- Knowledge of regulations and ability to communicate and apply.
- Ability to identify compliance risks and escalate when necessary.
- Excellent verbal and written English communication skills, suitable for multi-location working relationships.
- Demonstrated teamwork and collaboration skills.
- Aptitude for Attention to Detail.
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