Exciting opportunity to join a growing pharmaceutical company as a Regulatory Affairs Specialist with lots of room to grow you career!
location: Irvine, California
job type: Permanent
salary: $80,000 - 90,000 per year
work hours: 9 to 5
- Provides regulatory assistance during the ANDA / NDA submission and approval process.
- Assists in company Standard Operating Procedures (SOP's) development and review.
- Develop and assess strategies for regulatory approvals for NDAs and ANDAs by providing input for product development through commercialization.
- Assists in reviewing documents for regulatory compliance necessary for the acceptability of quality documentation for submission filing.
- Assists in developing pre-approval compliance activities during manufacturing of submission batches.
- Performs label development and reviews for compliance.
- Monitors impact of changing regulations on submissions.
- Monitors and submits applicable reports to regulatory authorities as required.
- Maintains annual licenses, registrations, listings and patent information as required.
- Prepare annual reports for NDA / ANDAs by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to an application and tracking progress of their preparation.
- Review of documents and interacting with multiple departments (QA, Manufacturing, Project Management, Engineering, PD, etc.) which provide information and documentation utilizing the change control database to ensure accurate reporting to FDA.
- Assist in maintaining approved NDA / ANDAs current by requesting revisions to technical documentation as part of the annual report preparation process.
- Provide a critical detailed review of technical documentation including labeling, distribution reports, analytical procedures, product specifications, manufacturing and packaging batch records, in-process specifications, etc. prior to FDA submission.
- Assist in the preparation, revision and approval of labeling.
- Assist in the preparation and submission of required post approval reports such as field alert reports, periodic adverse drug experience reports etc. Ensures product safety issues and product-associated events are reported to regulatory agencies.
- Ensures compliance with product post-marketing approval requirements, annual reports, drug listings, labeling, pharmacopeia changes (pre and post approval), etc.
- Reviews regulatory aspects of contracts with customers.
- Provides regulatory support for product recalls and recalls communications.
- Bachelor's degree in science field (Biology, Chemistry, Microbiology, and Pharmacy).
- 10+ years' of experience in a regulatory function within pharmaceuticals (preferred) or medical products; experience in quality assurance and/or compliance may be considered.
- Certification such as RAC from the Regulatory Affairs Professionals Society preferred.
- Experience with electronic regulatory submissions.
- Knowledge of USP, and Code of Federal Regulations 21 CFR 111, 11, 210, and 211. FDA/ICH guidance and the regulatory process pertaining to drug development and approval.
- Able to handle multiple high priority assignments.
- Advanced technical writing skills and acute attention to detail.
- Ability to read and interpret complex technical documents. Ability to write comprehensive reports.
- Strong communication skills, both written and verbal.
- Able to build rapport at all levels of the organization as well as with external contacts.
skills: NDA, Regulatory Affairs Strategy, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.