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Reg Affairs Specialist

Req #: 1700083M_en
Location: Bloomington, IN US
Job Category: Regulatory Affairs
Date Posted: 11/16/2017 2:41:47 PM
Baxter International
About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Essential Duties and Responsibilities
  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
  • Prepare, review, and validation packages and SOPs. 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
Qualifications for this role
  • To perform this job successfully, an individual must possess the following:
  • Exercise independent judgment
  • Scientific knowledge
  • Written and Verbal communication skills
  • Knowledge of regulations
  • Strong Negotiation skills
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Manage multiple projects and deadlines
  • Ability to identify compliance risks and escalate when necessary
Education and Experience
Bachelor's degree or country equivalent in pharmacy or related scientific discipline with a minimum of 2 years regulatory or equivalent experience within a medical device / pharmaceutical company, CRO, or similar organization. Higher degree/PhD will be an advantage.

A Career That Matters
Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day. 

Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.
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