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Regulatory Affairs Specialist

Req #: 180005DA_en
Location: Warsaw, MZ PL
Job Category: Regulatory Affairs
Date Posted: 3/23/2018 4:20:50 AM
Baxter International

Description

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.
Learn more about life at Baxter and watch our video!
 
 
Essential duties and responsibilities
  • 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
  • Compile and submit in a timely manner regulatory documents, according to regulatory requirements
  • Prepare review and approve labeling and SOP’s 
  • 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 deadline
  • 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
  • Maintain and update existing regulatory authorizations
  • Lead or represent Regulatory Affairs in project teams
  • May review promotional material for compliance with local regulation

Qualifications

Qualifications and skills
  • University degree in pharmacy or related scientific discipline
  • Fluency in English is required
  • Regulatory or equivalent experience within a pharmaceutical company CRO, or similar organization
  • Knowledge of regulations
  • Exercise independent judgment, ability to identify compliance risks and escalate when necessary
  • Excellent written and verbal communication skills
  • Strong negotiation skills
  • Technical systems skills (e.g. word processing, spreadsheets, databases, online research)
  • Manage multiple projects and deadlines 

 
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.
 
We offer:

  • Interesting position in an international organization - we are present in over 100 countries around the world
  • Opportunity to work in a company with an established market position – Baxter was founded in 1930s in American Deerfield and in Poland we have been operating for over 20 years
  • Space to develop the career and fulfill ambitions
  • Great office location - just next to Train Station Warszawa Powiśle and comfortable working environment - modern office, fruits and fresh juices once a week, broad range of benefits

Would you like to learn more about our business? Visit our profile on Linkedin.

 

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, disability/handicap status or any other legally protected characteristic.

 

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