Senior Associate Clinical Trials Regulatory Affairs

Amgen Inc. (IR); Rotkreuz; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Amgen Inc. (IR) in Switzerland seeks a Senior Associate Clinical Trials Regulatory Affairs to manage regulatory submissions for clinical trials with Swissmedic, ensuring compliance with local regulations and Amgen policy.

You will interact with Clinical Project Management, Global Study Operations, and other counterparts to prepare dossiers, maintain timelines, and communicate regulatory status across teams.

Qualifikationen

• Master’s or Bachelor’s degree in natural sciences.
• Relevant experience with regulatory submissions and/or study start-up in Switzerland (Swissmedic) or biotech/pharma/CRO industry.
• Excellent written and verbal communication skills in English and fluent German.
• Ability to plan, develop, and manage timelines across multiple projects.
• Strong relationship-building with health authorities, colleagues, managers and vendors.

Aufgaben

• Perform regulatory submissions in Switzerland to Swissmedic and compile submission dossiers.
• Execute regulatory activities for clinical trial projects per local regulations and Amgen policies.
• Act as Amgen’s local contact with Swissmedic to fulfill regulatory obligations.
• Maintain regulatory timelines and checklists; communicate status to internal teams and service providers.
• Escalate issues with risk mitigation plans and coordinate cross-functional responses.

Kenntnisse

Regulatory submissions

Clinical trials

Cross-functional collaboration

German language

English language

Ausbildung

Master’s or Bachelor’s degree in natural sciences

Jobbeschreibung

Career Category 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.

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

• 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

• 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.

Objects in your future are closer than they appear.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen