Regulatory Affairs Director - Indianapolis


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Regulatory Affairs Director

Indianapolis, Indiana

 

As the state capital, Indianapolis is the most populous city in Indiana. Downtown Indianapolis boasts the largest employment cluster in Indiana, with nearly 43,000 jobs per square mile. With a low unemployment rate in Marion County, Indianapolis is a great area for talented healthcare professionals to live. Whether you prefer to work in a hospital, clinic, home care or senior housing setting—Greater Indianapolis job opportunities in healthcare are abundant.



On Time Talent solutions is seeking a Regulatory Affairs Director who will be responsible for leading preparation of regulatory submissions to support global clinical development, product registration, and post-approval life cycle management. This position will provide overall leadership and regulatory direction on projects by working with internal program teams to develop regulatory strategy and development plans and will interface with external consultants and regulatory agencies in developing regulatory submissions.


Regulatory Affairs Director Responsibilities:

  • Work with multidisciplinary project groups in meeting established objectives; prioritize projects to meet internal and external deadlines; and provide regulatory guidance

  • Assist legal counsel and corporate clients who are primarily pharmaceutical, biotech, medical device and diagnostics companies, with complex regulatory and compliance issues

  • Provide leadership to resolve critical regulatory issues, bring the appropriate experts together as needed

  • Lead cross-functional efforts to deliver high quality submissions, e.g., INDs, CTA, orphan applications - Ensuring that Manager is aware of any major issues with the project, including any changes to plan or risks

  • Keep abreast of regulatory guidance and technical/scientific developments relevant to projects

  • Build a Regulatory Affairs department, manage budgets and project timelines, identify and address gaps in planning and resourcing


Regulatory Affairs Director Qualifications:

  • Bachelor’s degree in life sciences, chemistry, or a related discipline, advanced degree preferred

  • 10+ years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry

  • Demonstrated excellence in regulatory liaison/strategy including a broad understanding of international regulations, processes and issues in drug development

  • Flexibility and responsiveness in managing multiple projects in sometimes high-pressure situations simultaneously

  • Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box

  • Regulatory affairs certification (RAC) a plus

  • Knowledge of both GCP and GMP regulations

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  • download:
    Accepted file types: pdf, doc, docx, txt.

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