Senior Associate Regulatory Affairs

Senior Associate Regulatory Affairs

The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspects of the department and will support interactions with global regulatory authorities.

Specifically, you will be responsible for:

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  Represent Regulatory Affairs on study teams and closely collaborate with multidisciplinary teams and Clinical Research Organizations (CROs) to identify submission requirements, coordinate the content and development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities.
  
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  Compile regulatory submissions that meet ICH or FDA requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.
  
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  Prepare and manage routine submissions and related activities. Define timelines to ensure timely delivery of high-quality, compliant, accurate and complete regulatory submissions.
  
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  Assist in the development and implementation of SOPs and systems to track and manage product-associated events.
  
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  Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assist in assessment of regulatory implications for development and approval. Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
  
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  Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.
  
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  Work with manager on obtaining and developing required regulatory skills and knowledge.
  

Required Skills, Experience and Education:

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  Bachelor’s degree in a relevant field.
  
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  Two or more years prior experience in a Regulatory Affairs department at a drug or biologics company.
  
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  Familiarity with regulatory requirements for development of drug or biological products, including FDA regulations and guidance, and ICH guidelines.
  
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  Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in electronic document management systems.
  

Additional Skills:

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  Experience in global Clinical trials.
  
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  Experience in oncology drug development.
  
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  Experience with supporting the preparation and submission of large complex regulatory submissions.