Job Description

Job Title: Regulatory Affairs AssociateJOB PRUPOSEResponsible 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.RESPONSIBILITIESReviews 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.QUALIFICATIONSExercise 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.EDUCATION AND/OR EXPERIENCEBS degree in a scientific discipline with 2 to 5 years' experience in the Pharmaceutical Industry along with excellentcommunication skills is required. Two (2) years of regulatory exposure is preferred.What We OfferClean climate-controlled working environmentAnnual performance bonus potential401k employer match up to 6% of your contributions23 vacation/personal days11 paid Company holidaysGenerous healthcare benefitsEmployee discount programWellbeing rewards programsSafety and Quality is a top organizational priorityCareer advancement/growth opportunitiesTuition ReimbursementMaternity 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.Job SummaryJob number: 9127Profession: Regulatory & Medical Affairs, Pharmacovigilance

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