Tevapharm
Regulatory Affairs Associate II
Tevapharm, Fort Lauderdale, Florida, United States, 33326
Together, 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 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. Responsibilities include:Review final output of the compilation to ensure the submission meets Food & Drug Administration (FDA) expectations and requirements.Review change controls, make appropriate regulatory determination, and assure appropriate documentation is attached.Write, review, and compile documentation for submissions to FDA and 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 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.Electronic document management systems (EDMS), such as: Global Track wise software system, Veeva Vault software, and GLORYA Software.Enjoy a more rewarding choice
We 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.Teva’s Equal Employment Opportunity Commitment
Teva 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.
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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. Responsibilities include:Review final output of the compilation to ensure the submission meets Food & Drug Administration (FDA) expectations and requirements.Review change controls, make appropriate regulatory determination, and assure appropriate documentation is attached.Write, review, and compile documentation for submissions to FDA and 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 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.Electronic document management systems (EDMS), such as: Global Track wise software system, Veeva Vault software, and GLORYA Software.Enjoy a more rewarding choice
We 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.Teva’s Equal Employment Opportunity Commitment
Teva 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.
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