Regulatory Affairs Support Associate

Our mission at Amgen SA is to serve patients living with serious illnesses. We believe in the power of collaboration and innovation to drive progress in healthcare. As a Senior Associate Regulatory Affairs Fixed Term, you'll be part of a dynamic team working towards this goal.About the Role:This fixed-term position involves leading regulatory submissions,...

As a Senior Associate Regulatory Affairs professional at Amgen SA, you will play a critical role in ensuring that regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements. You will contribute to the filing plan for Mexico and work closely with cross-functional teams to share, discuss, and negotiate the strategy and...

Job Title: Associate Manager, Regulatory AffairsAbout Stryker GroupStryker Group is a leading medical device company that seeks a highly skilled and experienced regulatory affairs professional to join our team. As an Associate Manager, Regulatory Affairs, you will play a critical role in ensuring compliance with regulatory requirements for medical devices in...

Amgen SA is dedicated to serving patients living with serious illnesses. Our mission drives all that we do, from research and development to manufacturing and delivery of innovative medicines. As a Senior Associate Regulatory Affairs Fixed Term, you will play a critical role in ensuring regulatory submissions meet Amgen's corporate and local...

Transform the lives of patients by ensuring timely and compliant regulatory submissions for Amgen SA. As a Senior Associate Regulatory Affairs professional, you will play a pivotal role in maintaining the company's reputation for quality and innovation.In this exciting opportunity, you will be responsible for preparing, reviewing, and approving source text...

As a Senior Associate Regulatory Affairs Fixed Term at Amgen SA, you'll be responsible for ensuring regulatory submissions meet corporate and local requirements. This role involves developing filing plans, preparing promotional materials, and collaborating with cross-functional teams.About the Role:This position requires expertise in regulatory affairs, with...

Role OverviewWe are looking for a skilled Senior Associate to join our Regulatory Affairs team at Amgen SA. In this role, you will play a critical part in ensuring regulatory submissions meet corporate and local requirements.Key Responsibilities:Develop and implement local regulatory strategies to obtain marketing authorizations.Collate and distribute...

Elysian Biologics is dedicated to improving access to life-changing medicines and enhancing the understanding and management of diseases. We require a skilled Regulatory Affairs Coordinator to ensure compliance with national and international regulations, manage submissions, and maintain up-to-date documentation for product registration and lifecycle...

Job OverviewWe are seeking a highly skilled Regulatory Affairs Consultant to join our team at Pharmaceutical Research Associates, Inc. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with Cofepris regulations for drug promotion/advertising and labeling.The successful candidate will have excellent...

A Regulatory Affairs Associate must have a knowledge of the organization's basic consulting models and methodologies as well as basic knowledge of what services the department provides. A Project Leader must be technically competent and continually developing the skills as defined in the department, under general direction of his/her Line Manager and...

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Director to join our team at Merck Gruppe - MSD Sharp & Dohme. As a key member of our regulatory department, you will be responsible for ensuring compliance with local and international regulations, as well as developing and implementing strategies to maintain and enhance our regulatory...

What you will do-Coordinate the annual submission plan for new product registrations and renewals, aligning plans with COFEPRIS requirements and contributing to their development. Also, responsible for handling specific or challenging demands.Lead and manage a team of three individuals overseeing medical equipment regulatory submissions to COFEPRIS in...

Job DescriptionParexel International seeks a skilled Regulatory Affairs Specialist to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Manage the lifecycle of regulatory submissions, including preparation, review, and submission.Collaborate with cross-functional...

As a Study Start Up Coordinator at ICON, you will contribute to the success of our clinical research organization by playing a pivotal role in leading the initiation of clinical trials.Responsibilities include preparing and submitting regulatory documents, coordinating stakeholder interactions, and managing records of regulatory submissions and...

At ICON, we are seeking a highly skilled Regulatory Affairs professional to join our team as an Associate Director of Pharmaceutical Compliance. This role will be responsible for providing strategic regulatory advice to internal stakeholders on communications regarding investigational product pipeline assets and approved prescription...

Direct message the job poster from Elysian BiologicsTalent Acquisition Leader | Diversity & Inclusion | StartupsAbout Elysian Biologics:At Elysian Biologics, we are committed to making life better for patients. Our mission is to improve access to life-changing medicines and enhance the understanding and management of diseases. We are looking for passionate...

Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Elysian BiologicsTalent Acquisition Leader | Diversity & Inclusion | StartupsAbout Elysian Biologics:At Elysian Biologics, we are committed to making life better for patients. Our mission is to improve access to life-changing medicines and enhance the...

Company Overview:Teva Pharmaceuticals is a leading manufacturer of generic medicines and the proud producer of many products on the World Health Organization's Essential Medicines List. With operations in nearly 60 countries, we strive to make good health more affordable and accessible.The Opportunity:The Regulatory Affairs Manager will ensure compliance...

About the RoleThe Regulatory Affairs Lead will be responsible for ensuring Gilead Sciences, Inc. meets the required regulatory standards.Key ResponsibilitiesCollaborate with contractors of outsourced activities ensuring site readiness for inspection.Observe and enforce Corporate Ethical Business Practices and oversee the implementation of Global quality...

Key Performance IndicatorsThe Regulatory Affairs Specialist will be responsible for ensuring the accuracy, completeness, and timeliness of medical writing deliverables, adhering to regulatory standards and company policies. Key performance indicators will include:Timely completion of medical writing projects;Accuracy and quality of written content;Compliance...