Senior Specialist Regulatory Affairs (m/w/d)

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 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class 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 don’t 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.

Your role at Baxter

As Sr. Specialist Regulatory Affairs (m / f / d) within our Kidney Care Segment you will maintain regulatory files and provide regulatory advice to project teams.

This role is based in Hechingen / Baden-Württemberg

What you'll be doing

With direction, develop and execute regulatory project plans

Identify and elevate key areas of regulatory risk

Maintain regulatory files in a format consistent with requirements

Maintain awareness of regulatory requirements; identify relevant requirements

Participate as an active team member and provide regulatory advice to project teams as required

Respond to questions from regulatory authorities within strict timelines

Compile and submit, in a timely manner, regulatory documents according to regulatory requirements

Maintain and update existing regulatory authorizations

Support regulatory activities relating to specific portfolio of products / projects

Prepare, review, and approve labeling and SOP’s

Represent or lead Regulatory Affairs in small project teams

What you'll bring

Bachelor’s degree or country equivalent in a scientific discipline

Regulatory or equivalent experience within a pharmaceutical and / or medical device company, CRO, or similar organization

Knowledge of regulations

Scientific knowledge

Project management skills

Manage multiple projects and deadlines

Ability to multitask and prioritize

Interpersonal and communication skills

Negotiation skills

Technical system skills (e.g., word processing, spreadsheets, databases, online research)

Ability to identify compliance risks and escalate when necessary

Fluent German and English language skills

Have we sparked your interest?

IND-DACH