Regulatory Affairs Specialist-Principal at Baxter
Skaneateles Falls, New York, USA -
Full Time


Start Date

Immediate

Expiry Date

11 Aug, 25

Salary

96000.0

Posted On

11 May, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Responsibilities

YOUR ROLE AT BAXTER

Responsible for the implementation of complex regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products. Serves as a consultant to managers.

WHAT YOU’LL BE DOING

  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements.
  • Prepare, review, and approve labeling and SOP’s. Assist lower level team members on complex issues.
  • Provide regulatory advice to project teams.
  • Provide guidance and coaching for areas of responsibility to lower level team members.
  • Respond to regulatory authorities questions with strict deadlines.
  • Maintain regulatory files in a format consistent with requirements.
  • Develop and initiate complex regulatory project plans.
  • Manage regulatory activities relating to specific portfolio of products/projects (product owner).
  • Maintain and update existing regulatory authorizations.
  • Lead or represent Regulatory Affairs in project teams.
  • May review promotional material for compliance with local regulations.
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