Sr. Regulatory Affairs Associate
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
- 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.