International Regulatory Affairs Senior Specialist

Acino Pharma

Completes low and medium regulatory complex assignments

• Plans, prepares, compiles and submits high-quality regulatory applications in compliance with applicable requirements for each region/country
• Prepares electronic submission files in the document management tool docuBridge and submits regulatory dossiers via CESP (EU) and the portal of Swissmedic (CH)
• Prepares electronic submission files in the electronic document management system and dispatches them to Regional Regulatory Affairs Teams or third parties
• Tracks the status of applications under regulatory review and provides updates to the regulatory team or other internal/external stakeholders
• Revises and approves artwork of product packaging material in internal system, according to applicable guidelines
• Schedules meetings with internal stakeholders, third parties or regulators and develops and organizes material for these meetings and participates at these meetings
• Maintains ARCERA s internal regulatory information management system, and other databases
• Uploads product information texts to health authority webportals
• Calculates and tracks sunset clause dates and notification of supply interruption in EU markets and Switzerland
• Ensures regulatory compliance
• Adheres to standard operating procedures and other applicable legislation
• Communicates information on regulatory requirements to other departments
• Attends to internal trainings in due time
• Provides regulatory support to project teams, stakeholders and customers, as required.
• Forwards all received Product Quality Complaints, Adverse Events, and Medical Information Requests to the relevant person in Quality Assurance, Pharmacovigilance, and Medical Affairs
• Performs other tasks under the direction of the Manager within the agreed type of work

Key Skills:

• Acts in accordance with ARCERA principles and values
• Good communication skills, both verbal and written, with a passion for accuracy and attention to detail.
• Good interpersonal skills ability to effectively interact with a diverse group of people from different functions, of different nationalities and at different levels within the company or external business partners.
• Good project management skills.
• Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.