Regulatory Affairs Associate II

Who We AreTogether, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityActavis 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.Enjoy a more rewarding choiceWe offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.Already Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career SiteThe internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.Teva’s Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.Important notice to Employment Agencies - Please Read CarefullyTeva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.