Regulatory Affairs Senior Manager Cell Therapy

Regulatory Affairs Senior Manager Cell Therapy

Job Description
We are looking for a unique individual who is passionate about advancing therapeutics 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 can be based in UAE or KSA reporting to the Director of Regulatory Affairs. The successful candidate will lead the regulatory strategy and execution of the Cell Therapy (Kite Pharma) programs including NDA and life cycle submissions in the Middle East Region.

The role involves close cross-functional collaboration with a diverse number of stakeholders both internally and externally to:

• Support the definition, setting, and oversight of regulatory strategies to maximize regulatory success towards achievement of the program objectives, in conjunction with local, regional, and global teams.
• Provide strategic and tactical advice to achieve timely and efficient regulatory submissions, for Cell Therapy product applications and life cycle maintenance submission, while ensuring compliance with applicable regulatory requirements and internal policies and standards, in UAE and KSA.
• Engage with the broader Regulatory community within Gilead, and contribute to cross-functional initiatives representing the regulatory function and interacting with a diverse number of stakeholders.

Primary Responsibilities

• Lead regulatory submissions for new applications and life cycle maintenance in UAE and KSA and other territories as required in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, regional requirements, and scientific and company policies and procedures.
• Accountable for regulatory submissions and approvals and all related activities, in collaboration with internal and external stakeholders, ensuring delivery of the regulatory strategy in other territories for new applications and life cycle management (training will be provided).
• Ensure project team colleagues, line management, Regulatory Affairs Head in KSA and key stakeholders are appraised of developments that may impact regulatory success, exercising sound judgement and communicating in a timely manner.
• Responsible for anticipating and quantifying risks and proposing solutions with the probability of success.
• Be accountable for establishing strong working relationships with the RA Therapeutic liaisons/regulatory central team, Regulatory Head in KSA, other functions as required and including distributors to ensure global regulatory submissions are provided to local representatives in compliance with local regulations and to maintain compliance.
• Participate in or lead departmental and cross-functional taskforces and initiatives.
• Actively monitor and anticipate trends that impact both the regulatory and access environment and adapt regulatory strategies in a timely manner.
• Facilitate manufacturing sites registration in line with national requirements.
• Point contact at the cross-functional and project team meetings.
• Be responsible for demonstrating Gilead leadership commitments.
• Review and approval of promotional and non-promotional materials, and coordinate local Health Authority's approval, in collaboration with the RA team in KSA.

Labelling and Packaging

• Develop local product labelling, in accordance with local requirements.
• Ensure 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.
• Maintain deep knowledge of country regulatory requirements and the impact thereof on cell therapy and communicate changes to project teams and senior management in a timely manner.

Regulatory Compliance

• 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

• Partner with market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product-specific value evidence topics, as applicable.
• Provision of guidance during preparation of promotional materials & activities; review and approve promotional materials in accordance with national legislation and Codes of Practice and company policies and procedures.

Skills and Requirements

• Excellent verbal and written English communication skills, including relevant technical/ATMP language skills.
• Must be knowledgeable of regulatory environment and guidelines in the KSA.
• Has a broad understanding of pharmaceutical manufacturing, change control, and global distribution systems.
• Experienced with liaising with local distributors and regulatory authorities with consideration given to the broader impact of decisions or issues arising from these interactions.
• Outstanding collaborative, problem-solving team player with excellent written and oral communication and organizational skills.
• Able to articulate complex regulatory affairs strategies and issues at all levels within the Company.
• Strong attention to detail, and history of success leading and working on multiple projects with tight deadlines.
• Must be able to facilitate effective interactions with Central RA, other departments, sites within the company, and with external organisations, distributors, & trade associations.

Education and Experience:

• BS, MS or PhD in a scientific discipline with 8+ years biotech and pharmaceutical Regulatory Affairs experience.
• Experience in Cell Therapy would be an advantage.