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For Companies At a Glance
- Tasks: Manage regulatory approvals for clinical trials and market products, ensuring compliance with all requirements.
- Company: Join AMGEN, a top-rated workplace in Portugal, fostering innovation and excellence in healthcare.
- Benefits: Enjoy flexible work arrangements, comprehensive rewards, and global career development opportunities.
- Why this job: Make a real impact on patients' lives while working in a diverse and inclusive environment.
- Qualifications: A scientific degree and experience in regulatory affairs are essential; strong communication skills are a must.
- Other info: Located in Lisbon's city centre, our office is a hub of creativity and collaboration.
The predicted salary is between 36000 - 60000 £ per year.
Join our team at AMGEN Capability Center Portugal, the number 1 company in Best WorkplacesTM Portugal (category 201-500 employees) by the Great Place to Work Institute. We have over 300 talented professionals from more than 35 nationalities, working across diverse areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance, General & Admin, Human Resources, Regulatory Affairs, and more. Located in Lisbon's city center, our AMGEN office fosters innovation, excellence, and inspiration. Join us at AMGEN and support our mission: To Serve Patients. Our work at AMGEN truly matters in people's lives.
LIVE WHAT YOU WILL DO
This critical role involves ensuring that Amgen acquires and maintains all necessary approvals to support clinical trials and market approved medicinal products. You will support one or more products from a regional regulatory perspective, ensuring compliance with all regulatory requirements and timelines. The responsibilities include:
- Defining and implementing regional needs in collaboration with relevant stakeholders.
- Planning and managing regulatory submissions for clinical trials and marketing applications, ensuring compliance with global and local requirements.
- Assisting in developing and executing regional regulatory strategies, including risk assessments and outcome forecasting.
- Providing guidance on regional regulatory documents and meetings aligned with global strategies.
- Offering regulatory guidance on mechanisms to expedite product development, such as FIH studies, Orphan Drug, Fast Track, and compassionate use.
- Supporting label negotiations and monitoring evolving regulatory policies, legislation, and competitor labeling to assess their impact.
WHAT WE EXPECT OF YOU
We value diverse contributions to serve patients. Our ideal candidate will have:
- A scientific degree and experience in a similar regulatory role.
- Knowledge of policies, procedures, SOPs, and legislation related to medicinal products.
- Understanding of regional regulatory procedures for MAs, CTAs, and post-approval changes.
- Knowledge of drug development processes and the ability to navigate international regulatory environments.
- Strong communication skills, proactive issue resolution, and conflict management abilities.
WHAT YOU CAN EXPECT FROM US
Opportunities for learning, development, and career progression globally. An inclusive community encouraging ideas, innovation, and risk-taking. Comprehensive Total Rewards including healthcare, financial, and career benefits. Flexible work arrangements.
APPLY NOW. Objects in your future are closer than they appear. Join us.
EQUAL OPPORTUNITY STATEMENT: Amgen is an Equal Opportunity employer. We consider all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. We provide reasonable accommodations for individuals with disabilities during the application and interview process. Please contact us to request accommodations.
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 relevant to the pharmaceutical industry in Portugal. Understanding local regulations and how they differ from global standards can give you an edge during discussions with interviewers.
✨Tip Number 2
Network with professionals already working in regulatory affairs, especially those at AMGEN or similar companies. Engaging with them on platforms like LinkedIn can provide insights into the company culture and expectations for the role.
✨Tip Number 3
Stay updated on recent changes in regulatory policies and legislation that could impact drug development. Being able to discuss current trends and their implications during your interview will demonstrate your proactive approach and industry knowledge.
✨Tip Number 4
Prepare to showcase your problem-solving skills by thinking of examples where you've navigated complex regulatory challenges in the past. This will help illustrate your capability to handle the responsibilities outlined in the job description.
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 requirements of 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 regulatory experience, and knowledge of drug development processes. 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 regulatory affairs and how your background aligns with Amgen's mission to serve patients. Mention specific examples of how you've successfully navigated regulatory environments or managed submissions in the past.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application demonstrates 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. Be prepared to discuss how you have navigated these in previous positions, as this will demonstrate your expertise and readiness for the challenges at Amgen.
✨Showcase Your Communication Skills
As a Regulatory Affairs Manager, strong communication is key. Prepare examples of how you've effectively communicated complex regulatory information to diverse stakeholders, ensuring clarity and compliance.
✨Demonstrate Strategic Thinking
Be ready to discuss your experience in developing and executing regulatory strategies. Highlight any instances where your strategic approach led to successful outcomes, particularly in fast-paced environments.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ability to handle regulatory challenges. Think of specific situations where you successfully resolved issues or expedited processes, and be ready to share those stories.
