Sr Specialist Regulatory Affairs
Sr Specialist Regulatory Affairs
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Job Description
About the job
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our $5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70year legacy in acute therapies and home and incenter dialysis to provide bestinclass care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space it will also offer meaningful work to those who join us.
At Vantive you will become part of a community of people who are focused courageous and dont settle for the mediocre. Each of us are driven to help improve patients lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Essential Duties and Responsibilities.
Create and review regulatory documentation for Drug Device and Combination product renewals and other life cycle maintenancerelated submissions.
Interact with nonregulatory support groups (i.e. manufacturing product stability quality clinical etc.) to request documentation necessary to support product renewals submissions
Track status and progress of regulatory documentation
Coordinate and compile responses to regulatory authority questions (under supervision)
Use an electronic document management system to compile documents to support submissions to Health Authorities
Answer internal queries for assigned products
Maintain Database of Regulatory Requirements for renewals
Support other regulatory processes as required including device establishment registration drug listing structured product labeling and processing requests for certificates and legalization.
Qualifications.
Knowledge of regulations
Scientific knowledge
Administrative and project management skills
Ability to contribute to multiple projects from a regulatory affairs perspective
Ability to multitask and prioritize
Interpersonal and communication skills
Technical system skills (e.g. word processing spreadsheets databases online research)
Proofreading and editing skills
Ability to independently identify compliance risks and resolve or escalate as necessary
Education and/or Experience.
6 years of regulatory experience within a healthcare environment.
Bachelors degree or country equivalent in a relevant scientific discipline.
Suitable candidates with a nonscientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification.
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Remote Work :
No
Employment Type
Full Time
