COORDINATOR - DRUG REGULATORY AFFAIRS

Position code: 4219 Position Title: COORDINATOR - DRUG REGULATORY AFFAIRS



Work Location: New Jersey - Nutley Corporate Headquarters



Major Responsibilities:

- Provides regulatory support related to chemistry, manufacturing and controls (CMC) to Pharma Development Regulatory (PDR) and technical personnel and teams that address predefined tasks associated with marketed products.

- Assists in the preparation of CMC regulatory submissions as defined by regulatory and departmental guidelines for submission to Federal Drug Administration (FDA) and with direction from others.

- Conducts the activities of local PDR and/or technical personnel to ensure that tasks are completed within defined due dates and meet regulatory and departmental guidelines.

- Manages routine regulatory projects, as assigned by others.

- Will assist in activities related to import and export of pharmaceuticals

Qualifications:

- BA/BS degree in pharmacy or a life science or relevant experience in the pharmaceutical industry

- Good communication, interpersonal and organizational skills

- Good analytical skills

- Ability to function under limited supervision

- Commitment to performance measures of time and quality