Regulatory Affairs Associate

Regulatory Affairs Associate

Job Purpose: Responsible for ongoing support of regulatory activities, including preparation and submission of Annual Reports, Annual Product Reviews, foreign registrations, change controls and labeling review and proofreading. Additionally, this position will support the preparation and submission of supplements and amendments to FDA for approval, which includes responding to any deficiency letters.

Responsibilities:

• Reviews and approves labeling for revisions to current products.
• Proofreads labeling drafts as requested by labeling.
• Drafts revised labeling (Package Inserts) for marketed products based on FDA requirements and/or Hikma proposed changes.
• Completes regulatory portion of Annual Product Reviews (APRs).
• Reviews change control requests and provides regulatory opinion with supervisor concurrence.
• Supports the collection of documents for foreign registration, including submitting requests to FDA for Certificate of Pharmaceutical Product.
• Provides regulatory support to teams and gives updates at regulatory staff meetings, as needed.
• Prepares and submits Annual Reports, supplements, amendments, and other correspondences to FDA.
• Keeps Hikma's Ruby database current for all injectable products.

Qualifications:

• Exercise independent judgment.
• Scientific knowledge.
• Written and Verbal communication skills.
• Strong Negotiation skills.
• Extremely strong accuracy and attention to detail.
• Ability to work independently, be flexible and accommodating as priorities may change.
• Technical system skills (e.g. word processing, spreadsheets, databases, online research).
• Manage multiple projects and deadlines.
• Ability to identify compliance risks and escalate when necessary.

Education and/or Experience:

BS degree in a scientific discipline with 2 to 5 years' experience in the Pharmaceutical Industry along with excellent communication skills is required. Two (2) years of regulatory exposure is preferred.

Location: Cherry Hill, NJ, US, 08003

Nearest Major Market: Philadelphia

Hikma Pharmaceuticals