Regulatory Affairs Operations Associate Jobs in New Jersey

Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.

Reports to labeling management in Regulatory Operations and Innovation.

Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).

May be responsible for managing projects, processes, or programs with manager oversight.

Experience and/or Familiarity with Structured Content is preferred

Excellent verbal and written communication and skills.

Regulatory experience in the cosmetic industry, with a particular focus of EU fragrance allergens is a plus.

IT Skills (Microsoft Office, SAP, etc.)

Analytical skills and understanding technical scientific information

Strong written and oral communication skills are required. Strong interpersonal skills are important for working in fast-paced and matrix driven environment

Gathering, generating, and managing technical fragrance information

Provide Regulatory guidance, and support, including but not limited to:

• Experience with submission work in VaultRim

• Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER annual reports)

Qualified applicants will have the following expertise: