Senior Specialist Regulatory Affairs - Hechingen, Deutschland - BAXTER

BAXTER

Geprüftes Unternehmen

Hechingen, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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.
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 disciplineRegulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organizationKnowledge 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

Reasonable Accommodations

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