Regulatory Affairs Associate Director - Gulf Region

Regulatory Affairs Associate Director - Gulf Region

Job Description

Regulatory Affairs Associate Director, Gulf Countries, based in the UAE

We are looking for a unique individual who is passionate about advancing therapeutics, with creative problem solving skills to seamlessly meet the business needs while maintaining regulatory compliance. This is an exciting opportunity for an Associate Director to join the Regulatory Affairs team built on a strong sense of teamwork and excellence. The position is based in UAE reporting to the Director of Regulatory Affairs, Middle East Region. The successful candidate will lead the regulatory strategy, and execution plan for Gilead portfolio in Gulf Countries.

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

• Lead 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, including new applications and life cycle maintenance activities, while ensuring compliance with applicable regulatory requirements and internal policies and standards.
• 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 Gulf Countries, 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.
• Ensure project team colleagues, line management, and key stakeholders are appraised of developments that may impact regulatory success, exercising sound judgement and communicating on 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, other functions as required, and including distributors to ensure global regulatory submissions are provided to local representative in compliance with local regulations and to maintain compliance.
• Participate in or lead departmental and cross-functional taskforces and initiatives.
• 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.

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.
• Ensure maintenance of serialization, Track & Trace system, and e-label project, in collaboration with relevant internal & external stakeholders.
• Liaise with PS and Central Regulatory Affairs, regarding submission of Urgent Safety Restrictions, in line with the company policies and procedures.
• Coordinate submission of Dear Healthcare Provider Letters.

Regulatory Intelligence

• Maintain deep knowledge of country regulatory requirements and the impact thereof on Gilead portfolio and communicate changes to project teams and senior management in a timely manner.
• Actively monitor and anticipate trends that impact both the regulatory and access environment and adapt regulatory strategies in a timely manner.

Regulatory Compliance

• Ensures regulatory compliance with local regulations, guidelines, practices and Gilead’s policies and procedures.
• Maintain local Gilead’s SOPs and associated process documentation, as required.
• Act as Records Retention coordinator for the appropriate maintenance and storage of information according to agreed records retention schedules for regulatory affairs.
• Ensure Audit readiness and lead Regulatory topics during audit and inspections.

Access / commercial cross functional support

• Partner with market access colleagues to ensure efficient interactions with Regulators / Purchasers and HTA bodies, as needed, on product-specific value evidence topics.
• Provision of guidance during preparation of promotional materials & activities.
• Review and approve promotional materials in accordance with national legislation and Codes of Practice and Gilead’s policies and procedures.
• Supports tender (technical requirements) by coordinating through applicable channels, on timely manner, & maintain the related tracker accordingly.

Skills and Requirements

• Must be knowledgeable of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
• Work is performed under limited direction of a senior Regulatory Affairs professional.
• Excellent verbal and written English communication skills.
• Has a broad understanding of pharmaceutical manufacturing, change control, and global distribution systems.
• Experienced with liaising with local distributor 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.

Education and Experience:

• BSc. of Pharmacy or Degree in a scientific field.
• 10+ years’ Regulatory Affairs experience in biotech & Global R&D based pharmaceutical company.