Regulatory Affairs Associate

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

JOB PRUPOSE 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.

Job Title: Regulatory Affairs Associate

JOB PRUPOSE 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 elevate 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.

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave
• Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.