What are the responsibilities and job description for the Regulatory Affairs Associate position at Hikma Pharmaceuticals?
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
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
