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

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

QUALIFICATIONS

1. Exercise independent judgment.
2. Scientific knowledge.
3. Written and Verbal communication skills.
4. Strong Negotiation skills.
5. Extremely strong accuracy and attention to detail.
6. Ability to work independently, be flexible and accommodating as priorities may change.
7. Technical system skills (e.g. word processing, spreadsheets, databases, online research).
8. Manage multiple projects and deadlines.
9. 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.

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.

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