CMC Regulatory Affairs Manager

Job OverviewPosition Summary:As a key member of the Regulatory Affairs team, you will take on the role of Regulatory lead, overseeing submission planning and strategy for both developmental initiatives and existing FDA-approved products. Your expertise will be crucial in preparing high-quality ANDA submissions, including amendments, supplements, and Annual...

Job OverviewPosition Title: Senior Associate/Manager, Regulatory AffairsSalary: CompetitiveRole Summary:In this position, you will take on the role of Regulatory lead, overseeing submission planning and strategy for both development initiatives and currently approved products. Your primary responsibility will be to prepare high-quality ANDA submissions,...

Job DescriptionJob DescriptionSalary: Role Overview In this role, you will be a Regulatory lead for submission planning and submission strategy for development projects and existing (FDA Approved) products. You will be expected to prepare high quality ANDA submissions (including amendments, supplements and Annual Reports) with the support and oversight of...

Job OverviewSalary: CompetitiveRole Summary:In this position, you will take on the role of Regulatory lead, focusing on submission planning and strategy for both development initiatives and currently marketed products. Your responsibilities will include the preparation of high-quality ANDA submissions, including amendments, supplements, and Annual Reports,...

Overview: The Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This role involves actively contributing to the development and execution of regulatory strategies, regulatory submissions, and collaboration with...

Responsibilities: Manages most aspects of company regulatory interface with domestic and international health authorities. Manages the development and deployment of the regulatory program that ensures aggressive product approval. Manages and may generate regulatory submission documents for new products or changes to existing health authorities' filings,...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at iHealth Labs Inc. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our medical devices.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with FDA and...

Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream ofFree medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent...

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! Hybrid work arrangement Medical, Dental, Vision Benefits Health Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug Coverage Telehealth and Behavior Health Services Income Protection – Short Term and Long Term Disability Benefits Retirement Benefits - 401k Company Match on...

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...

About the RoleCorcept Therapeutics is seeking a highly skilled Director of Medical Writing and Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for leading the development of high-quality, strategically aligned medical writing deliverables that support our clinical development programs.This is...

Pay Range: $28-$32/hr ResponsibilitiesManages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.Acts as RA...

Purpose As our Senior Manager of Rates and Regulatory Affairs you will collaborate with the Transformation and Regulatory Teams, contributing to the success of rate case filings across multiple states and commodities. Reporting to the Senior Director, Rates & Regulatory Affairs, you will be instrumental in preparing regulatory materials and supporting...

If you're looking for the chance to learn, grow, and make a contribution to the community, look at employment opportunities with Full Sail University. You'll find your choice of career opportunities, great benefits, an environment that welcomes and values creativity, and a work experience that is both challenging and rewardingThis position will report to the...

Who We Are:ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...

Please apply if you think you are a good fit for the following: MUST have at least 5 yrs of REGULATORY STRATEGY experience Experience with IND submissions, preparing for meetings and briefing documents and FDA documents. IND; phase 1 and 2; Marketed products Dynamic fast paced environment TA; Anti viral, infectious disease, obesity drug, RSV; Any TA...

Please apply if you think you are a good fit for the following:MUST have at least 5 yrs of REGULATORY STRATEGY experienceExperience with IND submissions, preparing for meetings and briefing documents and FDA documents.IND; phase 1 and 2; Marketed productsDynamic fast paced environmentTA; Anti viral, infectious disease, obesity drug, RSV; Any TA background...

Please apply if you think you are a good fit for the following:MUST have at least 5 yrs of REGULATORY STRATEGY experienceExperience with IND submissions, preparing for meetings and briefing documents and FDA documents.IND; phase 1 and 2; Marketed productsDynamic fast paced environmentTA; Anti viral, infectious disease, obesity drug, RSV; Any TA background...

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in...

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...