Regulatory Affairs Consultant (APAC)

The regulatory affairs consultant for Asia Pacific will provide regulatory strategic and tactical leadership for drug development projects, including health authority interactions, regulatory submissions, clinical trial applications and other regulatory requirements in line with GARDP objectives, timelines and budgets. This role requires a deep understanding of local regulatory requirements and the ability to navigate complex regulatory environments.

Tasks and Responsibilities

• Preparation and submission of local Clinical Trial Application to regulatory authorities and IRB/IEC as soon as possible to obtain all necessary regulatory approvals within defined timelines.
• Primary responsible person for communication with RA and ECs during the clinical trial lifecycle.
• Manage and support the clinical research organization responsible for clinical trial applications for NEOSEP Part 2 to regulatory authorities and ethic committees in the Asian countries (Bangladesh, Vietnam, Malaysia, India and Pakistan).
• Complete regulatory intelligence on regulatory pathways for registration of old antibiotics in the Asian countries
• Manage and support the sublicensee responsible for the STI product registration in Asian countries.
• Assess and communicate the impact of relevant regulatory policies, regulations, country legislation in relation to the GARDP product portfolio.
• Compile and assesses regulatory intelligence to assist in the development of local, regional regulatory strategies.
• Develop new regulatory affairs policies, processes, and standard operating procedures for the GARDP RA system.
• Support the articulation of the regulatory requirements for the early access programs.
• Attend project team meetings (in absence of the HEAD of RA) to provide technical guidance and support on regulatory activities in Asia Pacific.
• Organize and man
• Mangement of regulatory documents and records for the GARDP products.

Point of Contacts and Interactions

The main point of contact is the Head of Regulatory Affairs of GARDP. He / She works closely with the GARDP programmes & project teams.

Position Requirements:

Knowledge and Skills:

• Good understanding of the regulations, directives and guidance supporting clinical Research and Development.
• Strong working experience with a variety of regulatory authorities is required, with real first-hand experience of managing clinical trial applications and product registrations with different regulatory authorities.
• Experience with regulatory authorities, Ethic Committees and Ministry of Health for the Asia Pacific countries.
• Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision.
• Strong ownership and oversight skills.
• Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach. Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Strong software and computer skills, including MS Office applications.

Education and Experience:

• Bachelor’s degree in pharmacy / science or Master’s degree.
• Minimum 5 years’ experience in Regulatory Affairs for Asia Pacific countries and clinical trial activities related to medicines is mandatory.

To Apply:

• Please submit your application using the online form
• Consultant Tax Registration number
• Deadline for applications: 8.12.2024
• From 1st of January to 31st of December
• Activity rate : 80%
• Please note that only shortlisted candidates will be contacted.