Regulatory Affairs Associate Director, Gcc

2 months ago

الرياض, Saudi Arabia Vertex Pharmaceuticals Full time

Job Description
- The GCC Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or implementation of global regulatory strategy for development programs or marketed products. This role will serve as a regional regulatory lead, for development and/or commercial product(s) within the Vertex portfolio and contribute to the global regulatory strategy for the assigned program(s). This role requires understanding of international regulatory affairs frameworks and importantly those of GCC/ Middle-East-Africa markets, drug development, and related concepts, and the ability to translate this knowledge into effective regulatory plans and strategies.
- 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 pathwaysProvides 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. Flex Designation:
Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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