Regulatory Affairs-Assistant Manager

Job ID 17-00269

Industry Pharma

Job Type Permanent

Location Denville, NJ


Major Areas of Responsibility
- Prepare and review technical documents ANDA submission and filing with the FDA.
- Prepare labels in SPL and address labeling deficiencies.
- Coordinate with Development teams to ensure compliance and to get documents for filing.
- Compile and review Original applications, Amendments, Supplements, Annual reports, PDAERs, Medwatch forms, drug listing, adverse event reports etc. for US FDA.
- Maintain and archive all regulatory submissions and maintain life cycle documents of all products filed with FDA.
- Maintenance of Electronic Submissions Gateway account and eCTD software.


Required Knowledge, Skills and Abilities
- Ability to enter data accurately.
- Ability to handle multiple tasks well.
- Ability to facilitate resolution of client issues
- Must have advanced skills in Microsoft applications
- Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders
- Excellent verbal and written communication skills
- Self-directed

Education and Experience
- Minimum BS Degree in Regulatory Affairs or Equivalent
- At least 2-3 years of pharmaceutical industry

Physical Demands
- This position requires the employee to routinely use a computer, Lab work

Work Environment
- General office