Regulatory Affairs Senior Manager

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
 

We are looking for a unique individual who is passionate about innovative medicines and with creative problem solving skills to seamlessly meet the business needs while maintaining regulatory compliance. This is an exciting opportunity for a Senior Manager to join the Regulatory Affairs team built on a strong sense of teamwork and excellence. This position is based in Riyadh and reporting to Reg Affairs Head based in the Kingdom of Saudi Arabia (KSA). The successful candidate will interact with Saudi Food & Drug Authority, provide input in regulatory strategy and execution including MAA and life cycle submissions in the KSA.  The role involves close cross-functional collaboration with a diverse number of stakeholders both internally and externally to:

• Provide strategic and tactical input to achieve timely and efficient regulatory submissions and maintenance, while ensuring compliance with applicable regulatory requirements,
• Engage with the broader Regulatory community within Gilead.
• Contribute to cross-functional initiatives in KSA, representing the regulatory function.

Job Responsibilities

Primary responsibilities

• Responsible of Regulatory file preparation and submission, in collaboration with Regional RA Therapeutic liaisons and cross-functional team, in line with national requirements and company policies & procedures.
• Reviews and advises on content of the registration files to fulfil local requirements and ensure smooth submission and review of the related application, as needed.
• Ensures execution of the registration plan for assigned products, in collaboration with Regional RA Therapeutic liaisons.
• Ensures maintenance of registered products in coordination with Regional RA Therapeutic liaisons, logistic/supply and commercial in order secure supply continuity.
• Tracks and facilitates manufacturing sites registration in line with national requirements.
• Updates and maintains registration status dashboard.
• Ensures consistent communication to internal/external stakeholders & partners.
• Performs all required reporting obligations
• Support the preparation of Health Authority interactions / meetings.

Labelling and Packaging

• Leads development of local product labelling in accordance with local requirements and in alignment with company policies and standards.
• Ensures Regulatory Labelling compliance and submission of safety updates in line with Health Authorities requirements & internal compliance deadlines.
• Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license.
• Ensures implementation of serialization project and Track & Trace system, in collaboration with relevant internal & external stakeholders
• Reviews Arabic translations and Artworks, as needed.

Regulatory Intelligence

• Keeps abreast of changes in legislation and regulatory requirements, assesses and communicates these changes to relevant stakeholders, project teams and senior management in a timely manner.

Regulatory Compliance, Quality & Pharmacovigilance

• Ensures regulatory compliance with local regulations, guidelines and practices.
• Implements Gilead’s SOPs and associated process documentation, as required.
• Acts as Records Retention coordinator for the appropriate maintenance and storage of information according to agreed records retention schedules for regulatory affairs.

Access / commercial cross functional support

• Provision of guidance and assistance to Gilead commercial team, for assigned products, during preparation of promotional materials.
• Review of promotional & non-promotional materials and activities in accordance with national legislation and Codes of Practice and company policies and procedures, & coordinate submission & Health Authority approval, where required.
• Supports tender requests & enlisting, for assigned products, by coordinating through applicable channels in order to gather the related technical requirements in a timely manner & maintain the related tracker accordingly.

Skills and Requirements

• Able to articulate complex regulatory affairs issues.
• Must be knowledgeable of local requirements.
• Plans, schedules and arranges own activities and may direct others in accomplishing objectives.
• Excellent organization skills and ability to work on a number of projects with tight timelines is required.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Excellent teamwork skills.
• Must be able to facilitate effective interactions within RA organization, and cross functional team.
• Fluent Arabic & English.

Knowledge, Education and Experience:

• BSc. of Pharmacy or Degree in a scientific field.
• 5+ years of relevant experience in Regulatory Affairs.
• Experience of working within a Global R&D based pharmaceutical company.

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