Hikma Pharmaceuticals · 12 hours ago
Regulatory Affairs Associate
Cherry Hill, NJ
Full-time
Onsite
Entry, Mid Level
2+ years expHikma Pharmaceuticals is seeking a Regulatory Affairs Associate to support regulatory activities including preparation and submission of reports and product reviews. The role involves drafting and reviewing labeling, managing regulatory submissions, and providing support to teams regarding compliance and documentation.
Health CareMedicalPharmaceutical
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
Qualification
Required
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 escalate when necessary
BS degree in a scientific discipline with 2 to 5 years' experience in the Pharmaceutical Industry along with excellent communication skills
Preferred
Two (2) years of regulatory exposure
Benefits
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
Career advancement/growth opportunities
Tuition Reimbursement
Maternity and Parental Leave
Company
Hikma Pharmaceuticals
Hikma focuses on a wide range of generic, branded generic and in licensed pharmaceutical products
5001-10000 employees
H1B Sponsorship
Hikma Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (23)
2023 (22)
2022 (24)
2021 (28)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
International Finance Corporation
2025-07-15Post Ipo Debt· $250M
2005-11-04IPO
Leadership Team
Said Darwazah
Chief Executive Officer
Khalid Nabilsi
Chief Financial Officer
Recent News
London Evening Standard
2025-12-16
2025-12-15
MarketScreener
2025-12-15
Company data provided by crunchbase