The role of the Regulatory Affairs Director is to lead GRTs within Amgen's GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency . In this vital role you will provide global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Organization: Local Regulatory Affairs. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. internally and externally with Global, Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. We use cookies to improve your experience on our site. New Amgen Regulatory Affairs jobs added daily. Regulatory Affairs Manager - CMC Live What you will do Let's do this. worldwide. Skip to Main Content. Its here. Coordination and execution of Regulatory Affairs processes and deliverables in the local office. Responsibility: Ensures regulatory submissions are made on time and meet company's corporate and local regulatory requirements. Let's change . Job posted 4 hours ago - Amgen Inc. is hiring now for a Full-Time Regulatory Affairs Director -General Medicine (Open to Remote) in Philadelphia, PA. View company reviews & ratings. Manager - US Regional Operations Lead (ROL), Senior Manager - Regulatory Data Analytics and Reporting (Open to remote), Clinical Research Medical Director, Thoracic Oncology - US - Remote, Associate Regulatory Affairs - CMC (JP10136), Senior Vice President and Chief Medical Officer, Head of Development, Regulatory Affairs Director, Global Regulatory Leader, Oncology (US-Remote). time At Amgen, our shared missionto serve patientsdrives all that we do. Manager (Northeast), Rare Disease Vasculitis Thought Leader Liaison Sr. Regulatory Affairs Sr. Development, Analytical Sciences, Quality Control, Supply Chain, and, Kuala Lumpur, This role will also manage, lead, and develop CMC regulatory staff in US and/or UK. 50 Amgen Regulatory Affairs jobs available on Indeed.com. )Show Salary Details. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview . Apply to Regulatory Affairs Manager, Senior Manager, . Algeria, Regulatory Affairs Sr. It is key to our becoming one of the world's leading biotechnology companies. Job posting for Regulatory Affairs Manager - CMC (Open to Remote) in Los Angeles, CA, US We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being. Regulatory Affairs Manager - CMC (Open to Remote), EOE including Disability/Protected Veterans. Gathering, consolidating and analysing regulatory intelligence for International Markets and supports its application to product-specific activities, Project management of submissions and monitoring status of applications, Provides guidance for and performs regulatory assessments of change control requests, Provide regional/country, product & regulatory expertise and clarification on International CMC RA requirements. Apply to Director of Regulatory Affairs, Global Medical Affairs Lead - Rocatinlimab (anti-ox40), Us- Remote, Fellow and more! Join us. other functions such as Commercial (US and Global), IR, Medical, Amgen Regulatory Affairs Jobs in United States, Regulatory Affairs Manager - CMC (Open to Remote), Companion / In Vitro Diagnostic Regulatory Affairs Manager (Open to remote), Executive Director, Global Regulatory Affairs, Therapeutic Area Head, Companion/In Vitro Diagnostics Regulatory Affairs Manager, Director, Access Strategy Lead, Cardiovascular (US Remote), Director - Global Quality Learning & Performance R&D (Global Medical), Companion / In Vitro Diagnostics Regulatory Senior Manager (Open to Remote), Marketing Senior Manager, Cardiovascular (US Remote), Commercial Business Development Forecasting and Analytics Senior Manager (US Remote), Supply Chain Sr. 32 Amgen Regulatory Affairs jobs available in California on Indeed.com. 26 Amgen Regulatory Affairs Manager jobs available on Indeed.com. Its time for a career you can be proud of. s change the world. Responsibility for the generation and execution of international country specific regulatory strategies. Oversee PR agency teams with clear direction while measuring results . If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen's Global Patient Safety team executes pharmacovigilance activities in collaboration with team members . Dismiss. **, Home View All Jobs (778) Results, order, filter Regulatory Affairs Manager Jobs Featured Jobs; Regulatory Affairs Manager. If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. We are global collaborators who achieve togetherresearching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager - CMC Live What you will do Let's do this. CMC specific regulatory knowledge and experience or in the manufacture/testing of pharmaceutical products. LIVE. Get email updates for new Regulatory Affairs Manager jobs in New York, NY. The International CMC team in collaboration with our local regulatory affiliates is responsible for developing CMC product strategy and the execution and delivery of regulatory submissions in International Markets.. We are all different, yet we all use our unique contributions to serve patients. Together, we in the . Apply to Regulatory Affairs Manager, Medical Director, Operations Manager and more! Amgen is the first regulatory consultancy to specialise in alternative proteins and we are passionate about helping companies of all sizes get these vitally important products through regulatory approval in the EU and other global markets . Search Lead regulatory affairs jobs with amgen. REGULATORY AFFAIRS SENIOR MANAGER INTERNATIONAL CMC. Job Type. We use cookies to improve your experience on our site. Advocate for Amgen and Global Regulatory Affairs by building relationships with key external stakeholders including senior regulatory agencies, trade associations, and influential professional bodies. The Regulatory Affairs Manager provides country regulatory expertise, plans and executes the Regulatory strategies for Amgen products in Malaysia. What. Leverage your professional network, and get hired. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. What you will do. At Amgen, our shared mission-to serve patients-drives all that we do. Become the professional you are meant to be in this meaningful role. Partners with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all company molecules. It is key to our becoming one of the world's leading biotechnology companies. Lets change the world. . It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients . Senior Associate Regulatory Affairs (CMC) At Amgen Breda medicines are labelled, assembled . Full-time (26) Location. Amgen jobs Gilead Sciences jobs Senior Representative jobs Public Relations Officer jobs . Amgen Jobs. Average Amgen Regulatory Affairs Manager yearly pay in the United States is approximately $110,165, which meets the national average. LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. . Reviews promotional and non-promotional materials. city, state, country. If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Partner with/support Global, Portugal, EOE including Disability/Protected Veterans. Become the professional you are meant to be in this meaningful role. Thousand Oaks, CA (30) San Diego, CA (1) Claremont, CA (1) South San Francisco, CA (1) Los Angeles, CA (1) Company. At Amgen, our shared missionto serve patientsdrives all that we do. Amgen is committed to the safety of our patients and safe use of our products in all countries where Amgen products are marketed. Amgen Regulatory Consulting provides scientific and regulatory advice to the alternative protein industry. Amgen Jobs. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. job title, keywords. Amgen Canada's facilities in Mississauga feature a state-of-the-art "green" design, as well as enhanced use of space with . Youve earned your degree. This is your opportunity to Live, Win, and Thrive with a world-renowned organization. 15 Regulatory Affairs Amgen jobs available in Remote on Indeed.com. We use cookies to improve your experience on our site. Regulatory Affairs experience. The estimated total pay for a Regulatory Affairs Associate at Amgen is $90,460 per year. Manager, International CMC, EOE including Disability/Protected Veterans. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million . . LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads) on and off LinkedIn. Easy 1-Click Apply (AMGEN INC.) Senior Manager - Regulatory Data Analytics and Reporting (Open to remote) job in New York, NY. job title, keywords. Please contact us to request an accommodation. This number represents the median, which is the midpoint of the ranges from our proprietary Total Pay Estimate model and based on salaries collected from our users. Advanced Bio-Logic Solutions. Coordination and execution of, Manager (Great Lakes), Supply Chain Sr. Join us. Thousand Oaks, CA (24) Washington, DC (2) Company. Direct experience with International market applications - MAAs or variations. New Amgen Regulatory Affairs Associate jobs added daily. Assist in aligning local regulatory requirements with Amgen's corporate standards. This role . You know that job youre proud of? Responsibility: Ensures regulatory submissions are made on time and meet company's corporate and local regulatory requirements. Key responsibilities of this CMC Regulatory Manager role include: Oversight of an external service provider including, but not limited to, direct interactions with the vendor, oversight of resources and ways of working, Supervising assigned team members with respect to management, training, and resource planning, Support of CMC filings including Investigational New Drug (IND)/Clinical Trial Applications (CTAs), Marketing Application/Authorization, post-approval supplement/variations, renewals and responses to agency request for information across countries, Collaboration with leadership across CMC Regulatory functions and other functional leaders, Leading process improvements and documenting CMC Regulatory processes, Providing expertise and guidance to interdepartmental and cross-functional teams, Coaching and supporting junior staffs career development. Japan, Senior Manager - Regulatory Data Analytics and Reporting (Open to remote), Buenos Aires, . In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Find jobs. Sign in to create your job alert for Amgen Regulatory Affairs jobs in United States. The average salary for a Regulatory Affairs Manager at Amgen Corporation is $118,657. Manager, International CMC, Cambridge, Our upgraded Applicant Tracking System will help you identify your ideal role with Amgen. It is key to our becoming one of the worlds leading biotechnology companies. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide Amgen Regulatory Affairs Sr. Today's top 60 Amgen Regulatory Affairs jobs in United States. See if you qualify! Search Regulatory affairs jobs with amgen. This is your opportunity to Live, Win, and Thrive with a world-renowned organization. At Amgen, our shared missionto serve patientsdrives all that we do. Apply to Medical Director, Operations Manager, Outcomes Manager and more! Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. Salary information comes from 24 data points collected directly from employees, users, and past and present job advertisements on Indeed in the past 36 months. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Manager (Southwest), Rare Disease Vasculitis Thought Leader Liaison Sr. Global Regulatory Affairs (GRA) provides global . Global Regulatory Affairs and Safety are part of the Research and Development function within Amgen. Become the professional you are meant to be in this meaningful role. Get notified about new Amgen Regulatory Affairs jobs in United States. Let's change the world. Manager (Southeast), Rare Disease Vasculitis Thought Leader Liaison Sr. Manager (West Coast), Rare Disease Vasculitis Thought Leader Liaison Sr. We are a team of regulatory professionals who thrive on the challenge and opportunity that leading innovative regulatory strategies provides. At Amgen, our shared missionto serve patientsdrives all that we do. Date Posted. Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered, Review and preparation of M2 and 3 components for International Clinical Trial Applications, Marketing Applications and post-market supplements/variations. Lets do this. To find out more, read our privacy policy. By creating this job alert, you agree to the LinkedIn User Agreement and Privacy Policy. Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 34 Amgen Regulatory Affairs Manager jobs available in California on Indeed.com. Please note that all salary figures are . US Regulatory Affairs ManagerLive. . function with link to, Our medicines have helped millions of patients in the . What you will do. Click the link in the email we sent to to verify your email address and activate your job alert. Visit PayScale to research regulatory affairs manager salaries by city, experience, skill, employer and more. View job description, responsibilities and qualifications. Program emphasis is in Regulatory Affairs Rotational Fellowship . In this vital role you will be responsible for developing and executing CMC regulatory strategies for new Marketing Authorization Applications, Clinical Trial Applications, and Post-approval Variations dossiers that comply with International country/region regulatory standards. You can unsubscribe from these emails at any time. Please contact us to request accommodation. Let's do this. In this key role you will manage an external service provider and internal staff members within the Regulatory Optimization of Tactical and Strategic Support (Roots2) team. Work externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. Join us. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Amgen (26) Experience Level . Job posting for US Regulatory Affairs Manager (Open to remote) in San Francisco, CA, US Join us. Get email updates for new Senior Regulatory Affairs Specialist jobs in London, England, United Kingdom .

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