Senior Associate Regulatory Affairs
Share
Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Career Category
RegulatoryJob Description
Join our team atAMGEN Capability Center Portugal number 1 company in Best WorkplacesTMhttps:// in Portugal in 2024 (category 201-500 employees) by the Great Place to Work Institute. We have a team of over 500 talented people and more than 40 different nationalities diverse areas of expertise and professional experience that are shaping the future of healthcare. This is your chance to explore a world of opportunities in different areas such as Cybersecurity Data & Analytics Digital Technology and Innovation Finance General & Admin Human Resources Regulatory Affairs and many Lisbons city center our AMGEN office fosters innovation excellence and inspiration. Come thrive with us at AMGEN supporting our mission To Serve Patients. What we do at AMGEN matters in peoples lives.
SENIOR ASSOCIATE REGULATORY AFFAIRS
Amgens Regional Regulatory Affairs team offers European regulatory leadership and execution across the development registration and lifecycle management of all Amgen molecules. The team thrives on innovation and collaborates cross-functionally to advance product strategies through regulatory authority interactions. Our team is seeking a motivated regulatory professional inspired by Amgens science to support our mission of serving patients.
LIVE
WHAT YOU WILL DO
Lets do this. Lets change the this vital role you will be assigned to one or more Amgen products and may support a Regional Regulatory Lead (RRL) or lead a program under the supervision of an experienced regulatory lead.
Key Responsibilities:
Execute the EU regulatory strategy and EU regulatory plans.
Prepare supportive documentation for regulatory deliverables including the management of clinical trial applications marketing authorizations and lifecycle management activities.
Use of Amgen systems and document management.
Ensure and support regulatory product compliance.
Work with policies and SOPs.
Build effective relationships and communication paths across local and functional organizations.
Enable efficiencies and seamless execution across the region countries.
WIN
WHAT WE EXPECT OF YOU
We are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced autonomous and collaborative professional with these qualifications and skills:
Minimum Requirements
Masters degree or Bachelors degree (scientific area) and 3 years of directly related experience.
Demonstrated experience in clinical trial regulatory affairs.
Previous experience in developing and maintaining CTA documentation in Europe (e.g. IMPDs IMPD amendments) is ideal.
Depth knowledge of EU legislation and regulations relating to medicinal products is ideal.
Adaptability and strong English communication skills both oral and written.
THRIVE
WHAT YOU CAN EXPECT OF US
As we work to develop treatments that take care of others we also care deeply for our teammates well-being and growth.
Vast opportunities to learn develop and move up and across our global organization.
Diverse and inclusive community of belonging where colleagues are empowered to bring ideas to the table take risks and act.
Generous AMGEN Total Rewards Plan comprising healthcare finance wealth and career benefits.
Flexible work arrangements.
Objects in your future are closer than they us.
EQUAL OPPORTUNITY STATEMENT
AMGEN is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
.Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
