Junior Regulatory Affairs Associate

Location: Warsaw, IN
Date Posted: 06-25-2013

This is a 6+ months contract position.

Job Summary
Responsible for assisting the team with regulatory filings as necessary to market products. This is an entry level position, providing training towards full competency in Regulatory Affairs (RA). This position requires an understanding of  products and their use as well as an understanding of the regulatory admissions process. May perform some or all of the following functions, depending upon their specific assigned focus:

Principal Duties and Responsibilities

  • Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions
  • Assists in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions 
  • May provide regulatory direction to development project teams as a core team member; develops regulatory strategy for new products 
  • Reviews proposed labeling for compliance with applicable US and international regulations
  • Writes package inserts
  • Reviews and evaluates promotion and advertising material for compliance with applicable regulations
  • Reviews proposed product changes for impact on regulatory status of the product


Expected Areas of Competence (i.e. KSAs) 

  • Demonstrated strong writing and communication skills
  • Strong attention to detail, ability to multi-task
  • Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products
  • Ability to function well as a member of the team and build relationships between RA and other areas of the organization
  • Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred
  • Basic computer skills, including Microsoft Office Suite


Education/ Experience Requirements

  • US Bachelor’s Degree in life sciences, technical (engineering) or related field (or non-US equivalent).
  • No formal RA experience required, two years preferred
  • Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred
  • A combination of education and experience may be considered



Regards
Harsha
harsha.tellakula@mphasis.com

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