Randstad USA Disability

Job Information

Randstad Sr. Regulatory Affairs Associate in Florham Park, New Jersey

Sr. Regulatory Affairs Associate

job details:

  • location:Florham Park, NJ

  • salary:$80,000 - $95,000 per year

  • date posted:Tuesday, May 7, 2019

  • experience:3 Years

  • job type:Permanent

  • industry:Professional, Scientific, and Technical Services

  • reference:28631

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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