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Regulatory Technical Manager

Company: Fresenius Kabi US
Location: Michigan
Posted on: June 9, 2021

Job Description:

Job Summary

The Regulatory Technical Manager has responsibility for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers. The Regulatory Technical Manager interacts with all levels in the organization. S/he participates in discussions with management and provides strategic regulatory guidance. The Regulatory Technical Manager interfaces with regulatory agencies, primarily the FDA, as it relates to submissions and other relevant topics.

  • This position can be worked remotely or you may choose to work out of our Lake Zurich, IL site.

Responsibilities

  • Define and implement regulatory strategies, including original A/NDAs. Revise regulatory strategy as necessary based upon scientific data, changes in the regulatory environment, global project direction, etc.
  • Anticipate and prepare appropriate mitigation strategies for complex product submissions
  • Recognize early developing adverse trends or gaps and brainstorm practical solutions for both short and long-term corrective actions
  • Propose and negotiate complex and technical issues to a successful outcome
  • Represent RA on project teams and providing regulatory guidance
  • Apply expert knowledge of industry conditions and opportunities for competitive advantage to make business recommendations
  • Train and coach others in regulatory requirements
  • Mentor regulatory scientists regarding the regulations
  • Work effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved
  • Possess and share expert knowledge of complex issues across Regulatory teams
  • Keep informed on professional and regulatory information and be current on regulatory guidelines and regulations
  • Provide comments and perspective on proposed regulations
  • Use persuasive communication to influence regulatory agencies
  • Prepare and file (complex) high-quality submissions to regulatory authorities (A/NDAs, Supplements, Amendments, Annual Reports, Annual Reports and DMF Updates)
  • Reviewing technical documents for cGMP and regulatory compliance
  • Actively seeks ways to improve team processes and areas for improvement
  • Pursue aggressive goals to deliver on-time business results
  • Develop and implement quality standards for RA
  • Demonstrate company core values in daily work
  • Maintain ongoing relationships with stakeholders and colleagues by establishing trust, transparency and collaboration
  • Will have achieved and garnered the respect of others within and outside the department on matters related to development and marketed drug applications. Has the ability to influence outside the scope of their authority
  • Dedicate time and energy to remove obstacles to facilitate achievement of project goals
  • Serve as a role model for effectively communicating with individuals in different functions and at different levels.

Job Requirements

  • Bachelor's Degree in a scientific discipline
  • 5+ years' experience in pharmaceutical with 3+ years' in Regulatory Affairs
  • Experience in preparing and filing complete A/NDAs, Supplements, Amendments and Annual Reports to FDA
  • Thorough understanding of the CFR, FDA/ICH guidelines and cGMPs, as they pertain to pharmaceuticals
  • Well-developed communication skills
  • Regulatory Affairs Certificate a plus

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.

Keywords: Fresenius Kabi US, Fargo , Regulatory Technical Manager, Other , Michigan, North Dakota

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