Manager Regulatory Affairs – Software

Baxter Healthcare Corporation (Bangl, 中国) 3天前发布

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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

[...] position will be responsible for supporting all regulatory activities associated with product development, new registrations and optimal lifecycle management of Baxter Renal Care software products. This position will interface with key business and cross-functional stakeholders to ensure that the commercial objectives are achieved. Specific activities may include submission planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project teams.
This is an important position within the Renal Care Regulatory Team, and is accountable for the relationship with the US Food and Drug Administration, along with other relevant regulatory bodies. It provides input and helps influence global regulatory strategies and is responsible for the local execution of Baxter’s regulatory initiatives in line with business goals.

Essential Duties and Responsibilities

  • Act as regulatory liaison to project core teams.
  • Responsible for working with other parts of the regulatory organization to achieve desired result.
  • May act as primary contact with US FDA and/or EMA for standard activities related to product development or complianc
  • Develop and execute global strategic plans and regulatory submissions for development or sustaining projects
  • Utilize regulatory knowledge to prepare submissions that will achieve desired results
  • Ensure identified standards and content requirements are met for regulatory submissions
  • Lead strategy development for responding to Health Authority inquiries or audits/inspections
  • Engage with business representatives on sub-teams to ensure regulatory activities are in alignment with business requirements
  • Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s)
  • Assist with maintenance activities for regulatory systems and procedures
  • Maintain regulatory files in a format consistent with requirements
  • Track of status and progress of regulatory documentation
  • Author, review, edit and proofread regulatory documentation
  • Maintain awareness of changing regulatory requirements
  • Execute and document regulatory risk strategies
  • May provide guidance and coaching for areas of responsibility to junior team members
  • Provide input into forecast for resource requirements for regulatory activities
  • Provide regulatory costs to project teams

Qualifications

  • Bachelor’s Degree or country equivalent in related scientific discipline
  • Advanced Degree / PhD will be an advantage
  • Minimum of 5 years’ experience in RA or related discipline
  • Experience in a healthcare environment required

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.

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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 e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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