Job Description

Manager of Regulatory Affairs

The Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making.

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  Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content.
  
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  Correspond and collaborate with company colleagues and departments to achieve alignment.
  
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  Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.
  
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  Perform regulatory research to inform business strategy. Assess and communicate risks.
  
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  Assure that there are no significant interruptions to the business due to regulatory compliance issues.
  
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  Collaborates across the organization at all levels, across functional groups, and with executive management.
  
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  Develop regulatory strategies to inform associated budgets, tools and specialized support. necessary for efficient operations.
  

Required Skills, Experience and Education:

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  Bachelor's Degree in a relevant field and at least 3 years of direct Regulatory experience.
  
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  Strong working knowledge of US FDA Pharmaceutical regulations and guidance.
  
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  Proven track record of successful submissions within a regulatory environment.
  
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  Exceptionally strong team player with excellent interpersonal and communication skills.
  
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  Detail-oriented with strong organizational skills and high-quality standards.
  

Preferred Skills:

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  Knowledge of EU EMA Pharmaceutical regulations and guidance preferred.
  
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  Direct experience with IND/NDA filings.
  

Job Tags

Remote job, Contract work,

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