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 industrys regulatory and scientific environment.

Your Responsibilities

1. 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.

2. 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.

3. 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.

4. 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.

5. 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 Bachelors 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)