Regulatory Affairs Manager📣 إعلان

Regulatory Affairs Manager, Saudi Arabia

Takeda is seeking a Regulatory Affairs Manager to join its team in Riyadh, Saudi Arabia. This full-time role is central to ensuring regulatory compliance and managing the product lifecycle for Takeda's portfolio within the country. The manager will be responsible for developing regulatory strategies and overseeing product applications, variations, and post-approval reporting obligations.

Role Purpose

The primary purpose of this position is to ensure that all Takeda products comply with the registration requirements of health authorities in Saudi Arabia. This involves providing strategic regulatory guidance, managing submissions, and supporting the entire product lifecycle from initial application through post-approval maintenance and renewals.

Key Responsibilities

• Collaborate with International Regulatory Affairs Strategists to provide regulatory strategies to relevant functional groups and management.
• Prepare and submit product applications, variations, post-approval reporting obligations, and provide general product lifecycle management support for Saudi Arabia.
• Ensure Takeda's products adhere to the registration requirements of health authorities in Saudi Arabia.
• Evaluate local business and regulatory registration requirements for investigational and marketed products, preparing regulatory assessment reports as needed.
• Offer guidance and advice on international regulatory environments, assessing the impact of new and changing regulations and requirements.
• Develop and maintain effective working relationships with business partners and service providers in Saudi Arabia, including local visits when necessary.
• Keep Takeda updated on the most recent registration requirements and procedures for manufacturers and products.
• Review registration files for final checks before submission to the SFDA platform or forwarding to local distributors.
• Place orders for chemicals and/or HPLC columns as requested by the SFDA Laboratory.
• Negotiate product pricing with the SFDA on behalf of Takeda.
• Receive and manage final registration certificates for products and/or manufacturing sites.
• Archive original registration certificates locally and distribute copies to relevant internal and external stakeholders.
• Maintain records of all registration certificates and notify International Regulatory Affairs and local distributors six months prior to expiry to initiate renewal processes.

Qualifications and Experience

• A minimum of 5-10 years of experience in Regulatory Affairs or a related field.
• Demonstrated ability to manage product applications, variations, and post-approval reporting obligations.
• Strong understanding of health authority regulations and registration requirements in Saudi Arabia.

Professional Attributes

The successful candidate must possess the ability to thrive in a fast-paced environment, effectively managing competing tasks and demands. This role requires strong organizational skills and the capacity to prioritize multiple regulatory initiatives simultaneously.

Location and Work Type

This is a full-time position based in Riyadh, Saudi Arabia. The role involves engagement with local business partners and regulatory bodies within the region.