Sr. Regulatory Affairs Associate

  • location: Florham Park, NJ
  • type: Permanent
  • salary: $80,000 - $95,000 per year
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job description

Sr. Regulatory Affairs Associate

job summary:
Our Client is seeking a Senior Regulatory Affairs Associate to join their team. Experience with launching generic pharmaceutical products is a plus.

 
location: Florham Park, New Jersey
job type: Permanent
salary: $80,000 - 95,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Author Module 1 and Product Quality sections for regulatory filings to US and International Health Authorities for new drug development and approved products.
  • Coordinate with external vendors such as Contract Manufacturing Organizations and Development Partners for new product development and provide regulatory strategy and guidance to comply with US FDA requirements.
  • Coordinate with Clinical Research Organizations for Bio-equivalence and/or vehicle studies in humans and compile Module 5 section in ANDA's/505b2 NDA's.
  • Submit Controlled Correspondence requests and Citizen Petitions as needed.
  • Participates in meetings with cross functional teams and
  • and external customers and provide regulatory strategy and guidance.
  • Perform eCTD and SPL compilation and publishing. Maintain communication log for all products.
  • May perform peer review for ANDA's for completeness and accuracy.
  • Provide regulatory support to the Marketing and Quality Assurance team with Change Controls, Labeling etc. and ensure compliance.
  • Monitors and maintains awareness of the US regulatory environment, assessing impact to regulatory affairs practices and procedures.
  • Prepare and submit Annual Reports and PADERs.
 
qualifications:
  • Bachelor degree in the life sciences, chemistry, pharmacy; Advanced degree is preferred.
  • Minimum two years of relevant experience in pharmaceutical/Biotechnology industry.
  • Understanding of US regulatory requirements; ability to interpret and apply the regulations to specific projects by referring to regulations as well as relevant FDA and ICH or other regulatory agency guidance documents.
  • Domestic and International Travel required -10%
 
skills: Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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