Description:
Key Duties And Responsibilities
- Contributes to and may lead the development and implementation of regional regulatory strategies for assigned projects in development through commercial stages informing the global strategy. Contributes to and may lead the development and implementation of regional regulatory strategy to inform the global strategy for certain projects
- Responsible for the regulatory aspects of the relationship with commercial partners in GCC
- Advises teams on regulatory requirements for development and approval pathways, including potential for expedited pathways
- Leads and oversees the process for preparation, submission, and approval of regulatory applications
- Provides strategic and technical regulatory input for key product development or registration documents
- Ensures compliance of regulatory submissions with current regulations and guidance
- Reviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy
- Advises cross-functional teams and senior management on regulatory risks, considerations, and strategies for program(s).
Key Requirements
- Specialized knowledge of global and regional regulatory affairs frameworks and guidelines
- Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology
- Comprehensive understanding of requirements and processes to maintain a product on the market, product labeling, reporting, and surveillance
- Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment
- Strong problem-solving skills
- Strong written and verbal communication skills, tailored to multiple audiences, to communicate difficult concepts and persuade others to adopt a different point of view
- Ability to effectively lead and work within a team environment
- Prior experience with major health authority submissions and health authority interactions within the region
- Bachelor's degree in Biology, Chemistry, or other related discipline
- Native/ bilingual proficiency in Arabic/ English
- Ability to travel within the GCC region as required
- Saudi citizenship is required.
Flex Designation
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status
In this Hybrid-Eligible role, you can choose to be designated as:
- Hybrid: work remotely up to two days per week; or select
- On-Site: work five days per week on-site with ad hoc flexibility