Regulatory & Medical Administrative Assistant - Roche Pharma

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The Opportunity

The Administrative Assistant provides comprehensive administrative and operational support to the Regulatory and Medical Affairs departments. This role is essential in ensuring smooth day-to-day functioning, supporting compliance documentation, meeting coordination, communication across cross-functional teams, and administrative support in order to ensure that services are provided in an effective and efficient manner.

This role requires skills that are detail-oriented, proactive, and familiar with the pharmaceutical industry’s regulatory and scientific environment.

Your Responsibilities

• General Administrative Support
• Provides administrative support thorough knowledge of company operations, policies and procedures
• Handles details of a highly confidential and critical nature
• Collects and prepares information for use in discussions/meetings of executive staff and outside individuals
• Makes high-level contacts of a sensitive nature inside and outside the company
• Works autonomously using extensive knowledge of established precedents and practices, receiving minimal guidance. Proposes improvements to complex processes and methods
• Regulatory Affairs Support
• Assist in the preparation, formatting, and submission of regulatory documents
• Maintain regulatory filing systems and ensure proper document version control
• Track regulatory submissions and correspondence with Health Authorities
• Support coordination of audits and inspections, ensuring timely collection of required documents
• Medical Affairs Support
• Schedule and coordinate medical advisory board meetings, congress participation, and internal scientific sessions
• Support preparation and logistics for Medical Enabler activities and Clinical Research activities
• Support and Help in submission of Clinical Trial Files to SFDA and ensure document all communications with SFDA
• Support in drafting and writing all letters and communications needed with SFDA related to Clinical Research
• Support team in submission of Patient educational materials to SFDA and ensure documenting all replies and archiving all approvals with tracking for all Patient materials
• License to Operate
• Ensure compliance with regulatory requirements and timelines for all communications and submissions to SFDA related to Regulatory, Medical & Clinical Research
• Ensure and maintain archiving all communications and approvals from SFDA and tracking documents validity
• Maintain high ethical standards in all activities related to Regulatory, Medical & Clinical Research activities with SFDA
• Working in networks
• Liaise with Quality, Clinical, and Compliance teams as needed for project alignment
• Track project timelines, deliverables, and follow-ups using project management
  
  
  

Who You Are

• A Bachelor’s degree is preferred; diploma or equivalent with relevant experience is accepted
• 2+ years of administrative experience, preferably in the pharmaceutical, healthcare, or biotech industry
• Familiarity with regulatory documentation and medical terminology is a strong plus
• Proficiency in Google system knowledge of document management systems (e.g., Veeva Vault, ShareDrive) is advantageous
• Works proactively and collaboratively with individuals and teams internally/ externally to build networks across countries and functions
• Fluent in English (spoken/written)
  
  

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.