Director, Regulatory Affairs

  • Full Time
  • US
  • 12/31/2021

Website Ascletis

Ascletis is an innovative R&D driven biotech and listed on Hong Kong Stock Exchange (1672.HK). Ascletis is committed to developing and commercializing innovative drugs in the areas of NASH, cancer, viral hepatitis, and HIV/AIDS for unmet medical needs in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization.

We value our employees as our greatest assets, and we are dedicated to providing an equal employment opportunity along with creating a positive work environment where courageous innovation is encouraged and expected. Our vision is to become a world-class biotechnology company. Our highly talented team of scientists and medical professionals are all passionately sharing this common vision, and we are excited to welcome any talented members to join the big family of Ascletis. We are looking forward to having you as a prospective member of Ascletis. If you’re interested in learning more about what we have to offer, please email your CV to hr@ascletis.com.

 

Director, Regulatory Affairs
JOB TYPE: Full-time
LOCATION: US

 

JOB SUMMARY:
The Director of Regulatory Affairs at Gannex (A Member of the Ascletis Group) will be responsible for developing and implementing global regulatory strategies for NASH development projects. The individual will manage regulatory aspects of compounds through all phases of development, post-approval, and life cycle of the product. The individual will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met. The individual will interact with US and EU regulatory agencies and business partners regarding development, regulatory, and registration strategies.

 

Responsibilities:

• Provide strategic and operational regulatory direction on NASH projects
• Use extensive knowledge of US, EU, and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals. Maintains awareness of the global regulatory environment and assesses the impact of changes on business and product development programs. Facilitate policy and development of the standard interpretation of global regulation
• Oversee the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met
• Review sections of IND/CTA, NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements
• Liaise and negotiate with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and expediting approvals of product and labeling changes
• Integrate functional expertise with business knowledge to solve problems and make good decisions for the overall business
• Recruit, develop, manage and train regulatory team both via direct and indirect reporting structure
• Build partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise
• Responsible for the development and implementation of regulatory processes

 

Requirements:

• Minimum 10 years of experience in the biotechnical or pharmaceutical industry, and a minimum of 6 years experience in a Regulatory capacity
• Preferred candidates will have regulatory experience working with both FDA and EMA for NASH.
• Thorough understanding of drug development process
• Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, developing and implementing regulatory strategies with a proven track record of accelerated regulatory accomplishments
• Strong business acumen and ability to make sound decisions that contribute to accelerated regulatory approvals
• Proven ability to deliver on goals within a cross-functional team/partnership

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