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Providing strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior...

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

• Cover the PRRC role when requested from the needs of the company (e.g. during the absence of the current PRRC)
• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.

• Confirms, certifies, and releases batches of products manufactured, ensuring all manufacturing steps have been performed in compliance with GMP, the marketing authorization of the relevant product, defined procedures, and current regulations.
• Confirms batches of products intended for clinical trials.