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Sr Principal Regulatory Affairs Specialist

Company: GPAC
Location: Saint Paul
Posted on: April 9, 2021

Job Description:

A biopharma company has an outstanding opportunity for a Director of Regulatory Affairs. This person will develop, maintain, and monitor policies, procedures, practices, and activities to assure compliance with all FDA standards.As a senior member of the team, you will work closer with the executive team to lead the Regulatory strategy. You will need to be comfortable with eCTD, NDA publishing, IND filings and maintenance. They need a leader with experience working in regulatory environments. The company offers a competitive compensation package - 6-figure income and a comprehensive benefit package. Apply now!Director of Regulatory Affairs Responsibilities:

  • Lead the regulatory efforts, including establishing and maintaining protocols, eCTD, IND filings, NDA publishing and record keeping.
  • Maintain close liaison with regulatory authorities and clinical, scientific, and manufacturing collaborators on matters that impact the regulatory responsibilities of the company.
  • Audit and monitor internal processes and contract facilities for compliance with regulatory requirements, including FDA, CE, and ISO in application to medical devices.
  • Within the management team, propose, develop and implement regulatory policies and strategies.
  • Design, develop, and deliver regulatory training to employees.Director of Regulatory Affairs Requirements:
    • 10+ years' regulatory experience required - advanced degree preferred
    • Proven ability to lead, establish, maintain and influence effective working relationships
    • Self-motivated, ambitious, and able to manage multiple people
    • Strong work ethic, problem-solving skills, and leadership abilities
    • Attention to detail and organizational skills a must
    • Deep and up to date understanding of regulatory guidelines.
    • Ability to proactively identify and anticipate risk of non-compliance and address themYou can email me directly at: All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 31 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

Keywords: GPAC, St. Paul , Sr Principal Regulatory Affairs Specialist, Other , Saint Paul, Minnesota

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