Sr. Regulatory Affairs Associate

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

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
  • 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.
  • 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.

easy apply

get jobs in your inbox.

sign up

related jobs