Regulatory Affairs Associate

Hikma Pharmaceuticals - Cherry Hill, NJ

Full-time - Mid Level

Cherry Hill, NJ

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About the position

The Regulatory Affairs Associate at Hikma Pharmaceuticals is responsible for supporting regulatory activities, including the preparation and submission of various reports and documents to the FDA. This role involves reviewing and approving product labeling, managing change controls, and ensuring compliance with FDA regulations. The associate will also maintain the Ruby database for injectable products and provide regulatory support to teams within the organization.

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.

Requirements

• Bachelor of Science degree in a scientific discipline.
• 2 to 5 years' experience in the Pharmaceutical Industry.
• Excellent written and verbal communication skills.
• Strong negotiation skills.
• Extremely strong accuracy and attention to detail.
• Ability to work independently and manage multiple projects and deadlines.
• Technical system skills (e.g. word processing, spreadsheets, databases, online research).
• Ability to identify compliance risks and escalate when necessary.

Nice-to-haves

• 2 years of regulatory exposure preferred.

Benefits

• Paid holidays
• Health insurance
• Tuition reimbursement
• Parental leave
• 401(k) matching
• Employee discount program
• Annual performance bonus potential
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Wellbeing rewards programs
• Career advancement/growth opportunities