Regulatory Affairs Specialist: FDA Submissions & Labeling

Hikma Pharmaceuticals; Cherry Hill Township (NJ); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Clean climate-controlled working环境

Annual performance bonus potential

401k employer match up to 6% of your贡献

23 vacation/personal days

11 paid Company holidays

Generous healthcare benefits

Employee discount program

Wellbeing rewards programs

Safety and Quality is a top priority

Career advancement/growth

Tuition Reimbursement

Maternity and Parental Leave

Job summary

Hikma Pharmaceuticals seeks a Regulatory Affairs Associate to support ongoing regulatory activities in New Jersey. The role covers annual reports, APRs, foreign registrations, change controls and labeling review.

Responsibilities include drafting labeling revisions, completing regulatory components of APRs, evaluating change controls, and submitting documents to the FDA. Strong attention to detail and independent work are essential.

Qualifications

• Requires scientific knowledge and independent judgment.
• Strong written and verbal communication skills.
• Excellent attention to detail and accuracy.
• Ability to manage multiple regulatory projects and deadlines.
• Experience with regulatory processes and safety labeling is preferred.

Responsibilities

• Reviews and approves labeling for revisions to current products.
• Drafs revised labeling (Package Inserts) for marketed products based on FDA requirements and Hikma proposed changes.
• Prepares regulatory portion of Annual Product Reviews (APRs).
• Reviews change control requests and provides regulatory opinion with supervisor concurrence.
• Supports 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.

Skills

Independent judgment

Scientific knowledge

Written and Verbal communication

Negotiation skills

Accuracy and attention to detail

Independence and flexibility

Technical system skills

Project management

Regulatory risk identification

Education

BS degree in a scientific discipline

Job description

Hikma Pharmaceuticals seeks a Regulatory Affairs Associate to support ongoing regulatory activities in New Jersey. The role covers annual reports, APRs, foreign registrations, change controls and labeling review.

Responsibilities include drafting labeling revisions, completing regulatory components of APRs, evaluating change controls, and submitting documents to the FDA. Strong attention to detail and independent work are essential.