Regulatory Affairs Associate - FDA Submissions & APRs

Hikma Pharmaceuticals; Cherry Hill Township (NJ); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Annual performance bonus potential

401k employer match

23 vacation/personal days

11 paid Company holidays

Generous healthcare benefits

Tuition Reimbursement

Maternity and Parental Leave

Job summary

Hikma Pharmaceuticals in New Jersey is seeking a Regulatory Affairs Associate to support ongoing regulatory activities, including preparation and submission of annual reports, APRs, and foreign registrations. The role involves preparing supplements and amendments to FDA submissions and responding to deficiency letters.

The candidate should have a BS in a scientific discipline with 2–5 years in pharma, strong communication skills, and the ability to manage multiple regulatory tasks with attention

Qualifications

• BS degree in a scientific discipline is required with 2–5 years' experience in the pharmaceutical industry.
• Two years of regulatory exposure is preferred.
• Strong written and verbal communication skills are essential.
• Excellent attention to detail and accuracy are required.
• Ability to work independently and adapt to changing priorities.
• Experience with word processing, spreadsheets, databases, and online research is expected.

Responsibilities

• Reviews labeling revisions for current products.
• Proofreads labeling drafts as requested by labeling.
• Drafts revised labeling (Package Inserts) to meet FDA requirements.
• Completes regulatory portions of Annual Product Reviews (APRs).
• Reviews change control requests and provides regulatory opinions with supervisor approval.
• Supports collection of documents for foreign registration and FDA submissions.
• Keeps Hikma’s Ruby database current for injectable products.
• Gives regulatory updates at staff meetings.

Skills

Independent judgment

Scientific knowledge

Written & verbal communication

Negotiation skills

Accuracy & attention to detail

Independent work

Technical skills

Multitasking / time management

Compliance risk identification

Education

BS degree in a scientific discipline

Job description

Hikma Pharmaceuticals in New Jersey is seeking a Regulatory Affairs Associate to support ongoing regulatory activities, including preparation and submission of annual reports, APRs, and foreign registrations. The role involves preparing supplements and amendments to FDA submissions and responding to deficiency letters.

The candidate should have a BS in a scientific discipline with 2–5 years in pharma, strong communication skills, and the ability to manage multiple regulatory tasks with attention