Senior Associate Clinical Trials Regulatory Affairs

Amgen; Schweiz; On-site; CHF 110,000 - 150,000; Full time

Job summary

Amgen Schweiz is seeking a Senior Associate Regulatory Affairs for Clinical Trials to lead regulatory submissions in Switzerland to Swissmedic and to compile submission dossiers across trials and programs.

The role requires a Master’s or Bachelor’s in natural sciences, strong experience with Swiss regulatory filings, fluent English and German, and the ability to plan timelines and manage multiple projects across time zones in a matrixed team.

Qualifications

• Experience with regulatory submissions and/or study start-up in Switzerland (Swissmedic) or biotech/pharma CRO.
• Excellent written and verbal English; fluent in German.
• Ability to plan, develop, and manage timelines; capable of handling multiple projects.
• Comfortable working independently across time zones in a matrixed team environment.

Responsibilities

• Perform end-to-end regulatory submissions for clinical trials in Switzerland to Swissmedic.
• Compile submission dossiers and maintain regulatory timelines and documentation.
• Act as Amgen’s local regulatory contact with Swissmedic and internal stakeholders.
• Coordinate with Clinical Project Management, Global Study Operations, and Pharmacovigilance.
• Provide regulatory timelines and requirements for submissions and approvals in project meetings.
• Escalate regulatory risks and develop mitigation plans.

Skills

Regulatory submissions

Swissmedic

Clinical trials

Timeline management

Education

Master’s or Bachelor’s in natural sciences

Job description

Regulatory

Job Description

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

SENIOR ASSOCIATE CLINICAL TRIALS REGULATORY AFFAIRS

LIVE

What you will do

In this vital role as Senior Associate Clinical Trials Regulatory Affairs you will be responsible for performing Regulatory submissions in Switzerland to Swissmedic, compiling submission dossier, execution of all regulatory activities for clinical trial projects and programs, according to local regulations and Amgen’s policy.

This position interacts directly with Clinical Project Management (Local Study Operations Managers), Global Study Operations, International Regulatory Team, CMC Global Product Leads, and Pharmacovigilance.

• Performs efficiently end-to-end Clinical Trials Regulatory submissions in the country for new and ongoing project(s) or programs, including and not limited to initial applications to Swissmedic, clinical protocol amendments, ICF amendments, quality (CMC) amendments, study periodic reporting, until the project is officially closed
• Acting as Amgen’s local contact with Swissmedic to fulfill regulatory obligations in alignment with global SOP and other supporting documentation.
• Seeks opportunities and standard methodologies with local and regional partners that will contribute to overall operational efficiency.
• Communicates overall regulatory status to internal teams and service providers.
• Attends to project meetings with cross functional department leads to provide regulatory timelines and requirements for regulatory submissions and approvals.
• Collaborates with internal team members to establish timelines and clarify regulatory requirements
• Maintains clinical trial regulatory requirements' database, including regular updates to checklists.
• Facilitates communication with the regional or local study team (e.g. Start-up Associates, Project Managers, Regulatory Affairs, Vendors, and Contracts Department) during the total duration of study, closely monitoring to ensure regulatory milestones are met.
• Escalates issues to leadership, including plans for addressing/mitigating risks/gaps.

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:

• Master’s degree or Bachelor’s degree in natural sciences
• Relevant experience with regulatory submissions and/or study start-up experience with technical knowledge performing Clinical Trial Applications in Switzerland (Swissmedic) or work experience in clinical research acquired while working on clinical trials for a biotech/pharma company or CRO
• Excellent written and verbal communication skills in English as well as fluent in German
• Ability to plan, develop, and manage timelines, including keeping them up to date.
• Comfortable managing multiple projects and priorities at the same time.
• Skilled at building and maintaining positive relationships with health authorities, colleagues, managers, and service providers.
• Able to work independently and asynchronously across time zones in a collaborative, matrixed team environment.

THRIVE

What you can expect of us

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.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request an accommodation.