- Regional exposure to manage different markets|Head of the Regulatory affairs scope
About Our Client
Our client is a leading biopharmaceutical company based in Paris, France, focused on drug development in oncology, rare diseases, and neuroscience. With a global workforce of around 5,000, their products are registered in numerous countries, and they maintain a strong presence in key markets.
Founded in 1929, the company has a long history as a family-owned business and is publicly traded on a major stock exchange. The founding family retains significant ownership and influence within the organization.
Job Description
- Product Registrations
- Collaborate on local strategic planning for new product registrations.
- Develop and monitor submissions for new products, ensuring compliance with regulations.
- Build and maintain relationships with government officials at the Ministry of Health.
- Ensure timely renewal of product registrations and company licenses.
- Prepare submissions for new and me-too products and manage amendments as needed.
- Review promotional materials for regulatory compliance.
Quality Assurance Compliance
- Develop and implement local Standard Operating Procedures (SOPs) in line with laws and corporate standards.
- Train personnel on effective quality standards.
- Manage Change Control activities and ensure compliance with corporate quality standards.
- Report customer complaints and support crisis management in recalls.
- Oversee audit preparations and report deviations.
Compliance and Governance
- Ensure product specifications align with registration requirements.
- Provide regulatory support for new product development.
- Represent the company at the Ministry of Health and industry associations.
- Identify business opportunities related to regulatory initiatives.
The Successful Applicant
- Good command in English with articulate communication style
- Proactive and strong in cross function communication
- Minimum: 5-10 years in Regulatory Affairs and Quality Assurance.
- Preferred: 10-15 years in the same fields.
What's on Offer
Collaborative and empowered working environment.
Contact: Jenny I Wang
Quote job ref: JN-092024-6538801
