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Detailed Description

The Director of Regulatory Sciences is responsible for leading in the management of regulatory activities associated with drugs, biologics, and combination products development programs in the JAPAC region. The job entails providing strategic input necessary for regulatory strategy deliverables as well as formal health authority interactions, i.e., submission, meetings, etc. The Director, JAPAC Regulatory Sciences will interface with clients on all matters of development and serve as the point person on assigned projects.
 

Essential Functions Include:

• Working as part of Global Regulatory Sciences, primarily on a local level, with a focus on the JAPAC region.
• Provide regional regulatory strategy advice in line with the global regulatory strategy (where applicable).
• Lead regional regulatory strategy and regulatory operations, may involve managing regional/local consultants.
• Local / regional general regulatory advice, regulatory dossier writing, coordination and writing TPP documents, local clinical trial regulatory applications preparation where applicable.
• Regular contact with health authorities, and leading health authority meetings where appropriate.
• All ongoing interactions with TGA regarding annual reporting.
• Oversight and responsibility for regional vendors and consultants where required.
• Maintaining current GMP clearance, new GMP clearance applications, generate post-market variation dossier, eCTD publishing and submission.
• Authoring new registrations/variations applications, working with subject matter experts as appropriate.
• Launch preparations.
• Global regulatory intelligence and internal database updates.
• Update/translation of product information.
• Review of artwork.
• Updates to compendiums, DSURs, etc as required.
• Support business development in the region, including contributing to proposals and budgets, and attending prospective client meetings.
   

Qualified candidates must have:

• Required: Bachelor's degree in a related field.
• Preferred: Advanced degree in a related field.
• Eight or more years as a Regulatory Affairs Manager within the pharmaceutical or biotechnology industry.
• Regulatory experience in Australia and New Zealand is essential, experience in Asian countries is highly desirable.
• Ability to engage with health authorities in resolving issues with submissions, including preparation and submission of successful investigational and
• marketing applications.
• Excellent working knowledge and application of Regulatory and Quality standards.
• Demonstrated ability to manage multiple and diverse projects concurrently.
• Experience leading cross-functional teams, directing the efforts of subject matter experts as the project needs dictate.
• Demonstrated ability to develop positive relationships and collaborations.
• Excellent oral and written communication with cross-functional collaboration skills.
• Strong analytical skills; a strategic thinker, planner and implementer.
• Will be client facing, need excellent presentation skills.
• Must understand the whole process of drug development.
• Must have excellent communication skills (verbal and written).
• Strong early phase development experience is required.