The opportunity
Actavis Laboratories FL, Inc. seeks a Regulatory Affairs Associate II (Weston, FL) to write, review, and compile documentation and data necessary for submission of assigned ANDAs (Approved Abbreviated New Drug Applications) and NDAs (New Drug Applications) with supervision from manager as needed. Review final output of the compilation to ensure the submission meets Food & Drug Administration (FDA) expectations and requirements, with supervision from manager as needed. Review change controls, make appropriate regulatory determination, and assure appropriate documentation is attached. Write, review, and compile documentation for submissions to FDA and to respond to FDA Deficiency letters. Compile data and documentation for a complete response. Review reports and documents where necessary. Work with RegOps and review final output of the compilation. Write, review, and compile documentation and data for correspondences and post-approval supplements. Compile data and documentation from the manufacturing and development sites based on internal checklists. Where necessary, review the reports/documents for accuracy and appropriateness. Work with RegOps and review final output of the compilation to ensure the submission meets FDA expectation and requirements. Write summary of submitted sections based on documentation and data provided using appropriate templates for ANDAs. Review applicable revised and new regulations and guidance distributed by the FDA. Train on internal SOPs (standard operating procedures) and requirements as applicable. Assist in providing regulatory strategy for assigned R&D and/or approved projects. Utilize previous experience and understanding of FDA guidance documents to provide suggestions to direct manager, or higher, regarding potential paths forward for proposals presented by R&D and/or Operations / Quality / Technical Services during development and submission. Inform R&D team of appropriate guidance with support from the direct manager, or higher. Local telecommuting permitted up to 2 days per week.
Your experience and qualifications
Bachelor’s degree or foreign academic equivalent in Regulatory Affairs, Drug Regulatory Affairs, Pharmaceutical Sciences, or a related field and 2 years of experience in the job offered or 2 years in a related occupation including Regulatory Affairs Specialist or related pharmaceutical regulatory experience.
Must have experience with:
Drug design, dosage form, clinical pharmacokinetic, and biopharmaceutics.
Pharmaceutical technology concepts, and operations.
US Food and Drug Administration regulatory guidance for pharmaceutical solid oral dosage forms.
Reviewing and approving regulatory and applicable documents for submission to the Food and Drug Administration (FDA) to ensure compliance with the current Agency’s guidelines and guidance.
Assessing and understanding the impact of FDA’s newly issued regulations and 21 CFR clauses for both pending and approved applications.
Regulations and compilations for both ANDAs – 505(j) and NDAs – 505(b)(2) applications.
Regulations and requirements for complex products such as peptides.
Regulations and requirements for combination products such as drugs-devices.
ICH (International Harmonization Committee) Quality guidelines.
Regulatory requirements for pharmaceutical product development as well as life cycle management of drug products.
And Electronic document management systems (EDMS), such as: Global Track wise software system, Veeva Vault software, and GLORYA Software.
THIS POSITION IS ELIGIBLE FOR THE EMPLOYEE REFERRAL PROGRAM.
Apply at https://www.tevapharm.com/your-career/; reference Req. 58068.
