Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Manage regulatory submissions and ensure compliance for clinical trials and medicinal products.
- Company: Join AMGEN, a top-rated workplace in Portugal, shaping the future of healthcare.
- Benefits: Enjoy flexible work arrangements and a generous rewards plan including healthcare and career benefits.
- Why this job: Be part of a diverse team making a real impact on patients' lives in a vibrant Lisbon office.
- Qualifications: Scientific degree and experience in regulatory affairs with strong communication skills required.
- Other info: Opportunities for growth and development in a supportive and inclusive environment.
The predicted salary is between 28800 - 48000 £ per year.
Join our team at AMGEN Capability Center Portugal, number 1 company in Best Workplaces in Portugal (category 201-500 employees) by the Great Place to Work Institute. We have a team of over 300 talented people and more than 35 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 more. In Lisbon's 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 people’s lives.
LIVE WHAT YOU WILL DO
In this vital role you will ensure that Amgen acquires and maintains all the required approvals to support clinical trials for investigational medicinal products as well as to market approved medicinal products. You will support one or more products from a regional regulatory perspective and ensure timely regulatory compliance with above approvals. The responsibilities of the role will include:
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
- Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
- Under supervision, assist in developing and executing regional regulatory strategies and processes in compliance with national requirements, including risk assessment and outcome forecasting under general supervision.
- Provide content guidance for regional regulatory documents and meetings in accordance with global strategy.
- Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans).
- Support regional label negotiation activities and regional product advancement by monitoring and researching evolving regulatory policies, legislation, and competitor labeling, and assessing their impact under supervision.
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 professional, are these qualifications and skills:
- Scientific Degree and experience in a similar role.
- Previous working experience with policies, procedures, and SOPs, and knowledge of legislation and regulations relating to medicinal products.
- Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions, and renewals.
- Knowledge of drug development and sensitivity to achieve results across both regional country and international borders.
- Strong communication skills, ability to anticipate and prevent potential issues as well as to resolve conflicts and develop a course of action leading to a helpful outcome.
THRIVE WHAT YOU CAN EXPECT OF US
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.
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.
Regulatory Affaris Manager employer: Amgen
Contact Detail:
Amgen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affaris Manager
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the pharmaceutical industry in Portugal. Understanding local regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in the Portuguese market. Attend industry events or join online forums to gain insights and make connections that could be beneficial for your application.
✨Tip Number 3
Stay updated on recent changes in legislation and regulatory policies affecting medicinal products. Being knowledgeable about current trends will show your proactive approach and readiness to tackle challenges in the role.
✨Tip Number 4
Prepare to discuss your previous experiences in managing regulatory submissions and compliance during the interview. Highlight specific examples where you successfully navigated complex regulatory environments, as this will showcase your expertise and problem-solving skills.
We think you need these skills to ace Regulatory Affaris Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Regulatory Affairs Manager position. Tailor your application to highlight relevant experience and skills that align with the job description.
Craft a Strong CV: Your CV should clearly outline your scientific degree, relevant work experience, and knowledge of regulatory procedures. Use bullet points to make it easy to read and ensure it reflects your achievements in previous roles.
Write a Compelling Cover Letter: In your cover letter, express your passion for the role and how your background makes you a suitable candidate. Mention specific experiences that demonstrate your ability to manage regulatory submissions and compliance effectively.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Amgen
✨Understand Regulatory Frameworks
Familiarise yourself with the specific regulatory frameworks relevant to the role. This includes understanding local and international regulations for medicinal products, as well as any recent changes in legislation that may impact the industry.
✨Showcase Your Communication Skills
As a Regulatory Affairs Manager, strong communication skills are essential. Be prepared to discuss how you have effectively communicated complex regulatory information to diverse stakeholders in your previous roles.
✨Demonstrate Problem-Solving Abilities
Prepare examples of how you've anticipated potential regulatory issues and developed strategies to mitigate them. Highlight your ability to resolve conflicts and lead teams towards successful outcomes.
✨Research AMGEN's Values and Culture
Take the time to understand AMGEN's mission and values, especially their commitment to serving patients. Be ready to discuss how your personal values align with theirs and how you can contribute to their inclusive community.
