Regulatory Affairs Specialist Job at Germer International - Pharmaceutical Recruiting, Madison, WI

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  • Germer International - Pharmaceutical Recruiting
  • Madison, WI

Job Description

Job Description

Responsibilities include :

  • Prepares global regulatory documentation and registration in support of customers and SPL business objectives.
  • Prepares and maintains Drug Master Files (DMF) for U.S. FDA.
  • Keeps with current EC drug substance or Active Pharmaceutical Ingredient (API) regulatory requirements.
  • Keeps current on U.S. FDA cGMP requirements.
  • Keeps current with Code of Federal Regulations (CFR) requirements for applications to DMF, IND and NDA documents.
  • Participates and supports customer and regulatory agency inspections.
  • Responsible for reviewing Quality Systems documents such as Change Controls and assessing applicability to the RA department.
  • Assists with reports and recommendations supporting updates and changes to evolving regulatory requirements.
  • Independently organizes, manages and meets critical timelines for regulatory activities.
  • Responsible for using electronic submissions formats such as Electronic Common Technical Document (ECTD).
  • Possesses good computer skills and apply this knowledge to new applications as needed.
  • Critical thinker with attention to details and the ability to articulate regulatory position or opinion to others in multi departmental meeting.
  • Maintains knowledge about regulations and regulatory trends for the U.S.A, Canada and EC.
  • Maintains knowledge about USDA importation and exportation requirements.
  • As needed assists with Annual Product Reviews (APR) and ensures correct information is captured in the regulatory files.
  • Performs other duties as assigned.

Job Requirements and Qualifications :

  • Education: Bachelor’s degree in a scientific or preprofessional field required
  • Experience: 2 plus years applicable GMP experience

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