Regional Regulatory Strategy Director

Caraway Therapeutics, Inc.; Singapore; Sur place; SGD 180 000 - 280 000; Plein temps

Résumé du poste

Caraway Therapeutics, Inc. is seeking a Regulatory Affairs Liaison (Associate Director) to oversee regulatory strategy for the Asia Pacific region, covering clinical, CMC, and risk management requirements.

The role includes regional labeling considerations and direct engagement with health authorities. You will serve as the regional lead, coordinating with HQ and country teams, driving submissions, and ensuring timely regulatory decisions while aligning strategy with portfolio goals and

Qualifications

• Bachelor degree in Pharmacy, Biological Sciences, Chemistry or related field with 10+ years regulatory experience.
• Fluent written and spoken English.
• Strong knowledge of regulatory requirements and processes for Asia Pacific region.
• Ability to manage multiple projects and work independently in cross-functional teams.
• Excellent communication and interpersonal skills.

Responsabilités

• Serves as single POC for specific products for country and HQ.
• Provides regionally focused strategic input to product development across region and across portfolio.
• Contributes to region specific aspects of a development strategy.
• Leads identification of regional specific elements of submissions.
• Owns and leads the overall regional product regulatory strategy, including the corporation and maintenance of regulatory requirements for health authority registration approval.
• Monitors and communicates key strategic issues related to program progress and issues to/from countries and HQ.
• Manage the execution of Health Authority (HA) Response to Questions (RTQ) for both product marketing and assigned applications, and helps ensure HA deficiency letters are appropriately addressed in a timely manner
• Ensures alignment of strategy and priorities for portfolio of products with stakeholders.
• Contributes to development and execution of regional regulatory policy issues.

Connaissances

Regulatory strategy

Regulatory submissions

HA interactions

Cross-functional collaboration

Formation

Bachelor's degree in Pharmacy, Biological Sciences, Chemistry, or related discipline

Description du poste

Caraway Therapeutics, Inc. is seeking a Regulatory Affairs Liaison (Associate Director) to oversee regulatory strategy for the Asia Pacific region, covering clinical, CMC, and risk management requirements.

The role includes regional labeling considerations and direct engagement with health authorities. You will serve as the regional lead, coordinating with HQ and country teams, driving submissions, and ensuring timely regulatory decisions while aligning strategy with portfolio goals and