Regulatory Affairs

Main Responsibilities:

Lead or participate in preparation of filing for assigned IND, CTA and NDA submissions to FDA or other health authorities. Might manage the interactions with FDA, EMA and other authorities. Provide regulatory support and guidance to cross-functional teams and ensure all applicable global regulatory requirements are considered and appropriately incorporated into clinical and commercial products. Function as RA representative in development project team. RA project lead will work closely with other functions of the company, including quality assurance, clinical development, pharmacovigilance, CMC, clinical operations, and project management. Is responsible for working with development teams to establish and implement global regulatory strategy and plan for assigned projects. Ensures that all internal and external due dates for regulatory milestones are met with quality deliverables. Might lead FDA or other health authority meetings or meeting rehearsals.


Minimum Requirements:
  • BS in Life Sciences or Chemistry required; advanced degree highly preferred
  • 7+ years of pharmaceutical or biotech industry experience
  • 5+ years of hands-on regulatory affairs project lead experience
  • Experience in filing IND and NDA for small molecule innovative drug is essential
  • Experience in establishing global regulatory strategy and plan for early and late development projects
  • Experience with interacting with FDA is essential, and global experience is highly preferred
  • Experience with oncology drug development is highly desirable

Location: Flexible locations in the United States

To apply, please send a cover letter and C.V. to moc.a1544542474mrahp1544542474egatn1544542474ecsa@1544542474RH1544542474.

Main Responsibilities:

Lead preparation and filing of regulatory CMC section of assigned IND, CTA and NDA submissions and manage the interactions with FDA, EMA and other authorities for CMC topics. Provide regulatory support and guidance to cross-functional teams and ensure all applicable global regulatory CMC requirements are considered and appropriately incorporated into clinical and commercial products. Ensure Ascentage’s CMC is cGMP and ICH guidance compliance. Assess CMC planned changes during development and provide guidance to CMC and report to health authorities as appropriate. Function as RA CMC representative in development project team. Might lead FDA meetings on CMC issues.


Minimum Requirements:
  • BS in Life Sciences or Chemistry required; advanced degree highly preferred
  • 7+ years of pharmaceutical or biotech industry experience
  • 5+ years of hands-on regulatory affairs CMC experience
  • Experience in authoring and reviewing eCTD CMC documents for small molecule innovative drugs
  • Experience in regulatory CMC for early and late development projects
  • Experience with FDA inspection and internal audit
  • Experience with FDA is essential and global experience is highly preferred

Location: Flexible locations in the United States

To apply, please send a cover letter and C.V. to moc.a1544542474mrahp1544542474egatn1544542474ecsa@1544542474RH1544542474.

Main Responsibilities:

Lead and provide overall quality assurance strategies for Ascentage clinical development. Define and execute overall quality assurance activities in collaboration with Clinical Operation, pharmacovigilance and CMC. Have thorough knowledge of GCP, EU Directives, ICH, and are familiar with current and emerging US and global guidelines and regulations and apply in the company’s clinical studies for the development of quality risk mitigation strategies. Perform risk assessments to identify audit targets, conduct internal and vendor audits, develop and maintain audit tools, checklists and plans, and author or review audit reports and other audit-related documentation. Ensures timely communication of QA issues including critical audit findings, potential misconduct or issues of significant deviation to stakeholders and management. Define and implement the health authority inspection strategies in support of the submissions and GCP compliance.


Minimum Requirements:
  • BS in Sciences required; advanced degree highly preferred
  • Must have 8+ years of pharmaceutical or biotech industry experience
  • Must have 5+ years of hands-on quality assurance lead experience
  • 3+ years of clinical trial monitoring and/or pharmacovigilance experience
  • Experience in leading internal and vendor audit is essential
  • Experience in leading FDA and other health authorities’ inspection are highly preferred

Location: Flexible locations in the United States

To apply, please send a cover letter and C.V. to moc.a1544542474mrahp1544542474egatn1544542474ecsa@1544542474RH1544542474.


Clinical Development

Main Responsibilities:
  • Development of protocols for clinical studies
  • Preparation of clinical development plans
  • Drafting of clinical scientific documents such as clinical section of IND, IND amendments Investigator Brochures, Annual Reports, Clinical Study reports, safety update reports and other FDA submissions, Risks / benefits analysis for applicable documents
  • Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies. Provide scientific expertise for selection of investigator and vendors. Monitor, review and summarize safety and efficacy data in ongoing studies
  • Assist with study design for exploratory development
  • Will lead the clinical matrix teams for assigned compounds
  • Develop relationships with appropriate consultants, contribute to or perform therapeutic area/indication research and competitor analysis
  • Interpret clinical data, prepare abstracts and present data at scientific meetings, both internally and externally
  • Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol

Minimum Requirements:
  • A medical degree (M.D./Ph.D. or equivalent) with significant scientific research experience required
  • Minimum of 15 years of experience in clinical research (including medical affair) with at least 5 or more years of drug development experience within other biotech / pharmaceutical companies are required

Location: Beijing, Shanghai or Guangzhou

To apply, please send a cover letter and C.V. to moc.a1544542474mrahp1544542474egatn1544542474ecsa@1544542474RH1544542474.

Main Responsibilities:
  • Accelerate the improvement of study quality by implementing Quality Assurance (QA) activities and driving quality initiatives, manage the quality risk of clinical studies in compliance with ICH-GCP, Chinese GCP, other related Chinese regulations, study related Standard Operation Procedures (SOP) of the company and study protocol
  • Support QA head to set up and maintain clinical quality management system, including study related SOPs at company level and electronic systems according to regulations
  • Carry out study audit, and support study teams and clinical QC personnel on inspection
  • Maintains current knowledge and understanding of regulations and industry practices in relation to clinical studies
  • Close collaboration with cross-functional stakeholders to track new or changes in local regulations or process

Minimum Requirements:
  • Bachelor degree or above in medical science or related field;
    Desirable: medical/pharmacological background
  • At least 2 years proven project management experience in clinical study
  • At least 2 years as Clinical Process Manager or equivalent
  • 2 years proven training or coaching experience
  • Good understanding of knowledge and skills required for the successful delivery of a clinical study, e.g. ICH-GCP, Chinese GCP, other study related regulations, study management, site management, monitoring
  • Understands the regulatory environments and the drug development process.

Location: Beijing, Shanghai or Guangzhou

To apply, please send a cover letter and C.V. to moc.a1544542474mrahp1544542474egatn1544542474ecsa@1544542474RH1544542474.

Main Responsibilities:
  • Responsible for monitoring Phase I-IV clinical studies independently
  • Ensure clinical studies are conducted at study site in compliance with ICH-GCP,Chinese GCP, other related Chinese regulations, related SOPs of the company and study protocol
  • Develop and maintain good working relationships with study site personnel and internal stakeholders to ensure smooth and timely delivery of clinical studies

Minimum Requirements:
  • Junior college degree or above of Medical Science or related field. Desirable: medical/pharmacological/nursing background.
  • Advanced monitoring skills, including study start-up, ongoing stage and study closure
  • At least 2 years working as CRA in pharmaceutical clinical research
  • Able to establish and maintain good working relationships with study site staff and study team members

Location: Beijing, Shanghai or Guangzhou

To apply, please send a cover letter and C.V. to moc.a1544542474mrahp1544542474egatn1544542474ecsa@1544542474RH1544542474.

Main Responsibilities:
  • Provide Pharmacovigilance (PV) support for patient safety risk management in clinical studies and life cycle management of responsible company product(s)
  • Partner with cross functional teams for safety reporting
  • Maintain current knowledge and understanding of regulations, ICH guidelines and industry practices in relation to pharmacovigilance (PV)
  • Keep abreast of new or changes in local regulations, process and industry practices

Minimum Requirements:
  • Bachelor degree or above of Medical Science or related field.
    Desirable: medical/pharmacological background.
  • At least 2 years working experience as PV physician or 2 years working experience as senior PV specialist in pharmaceutical company; clinical working experience is preferred 
  • Deep understanding of regulations, knowledge and practices required for pharmacovigilance, e.g. ICH guidelines, international pharmacovigilance regulation, Chinese regulations, industry practice, etc.

Location: Beijing, Shanghai or Guangzhou

To apply, please send a cover letter and C.V. to moc.a1544542474mrahp1544542474egatn1544542474ecsa@1544542474RH1544542474.

Main Responsibilities:
  • Lead the PV team to establish the PV operation and PV risk management framework, system and activities at Ascentage to comply with company policies and fulfill regulatory authorities’ requirements, and reach the target of mitigating risk.
  • Must ensure that the team is structured, staffed, trained and resourced to meet the needs of US PV management requirements
  • Maintains current knowledge and understanding of regulations, ICH guidelines and industry practices in relation to pharmacovigilance
  • Establish PV operation capability in safety data processing and the capability in patient safety risk management, provide support for drug safety monitoring in company products

Minimum Requirements:
  • Bachelor degree or above of Medical s
  • Science or related field,
    Desirable: medical/pharmacological background.
  • At least 12 years of pharmacovigilance working experience in a pharmaceutical company, rich experience in PV operation and PV risk management
  • Deep understanding of regulations, knowledge and practices required for pharmacovigilance, e.g. ICH guidelines, international pharmacovigilance regulation, Chinese regulations, industry practice, etc.
  • Strong interpersonal skills and communication skills, with the ability to work with others at all levels and from a wide range of backgrounds in the company (incl. internal and external)

Location: US

To apply, please send a cover letter and C.V. to moc.a1544542474mrahp1544542474egatn1544542474ecsa@1544542474RH1544542474.


Pharmaceutical Development

Main Responsibilities:
  • Direct and manage analytical teams in all aspects of routine operations, including staff hiring and development, daily operation, GMP compliance, budget, and expense tracking
  • Oversee and coordinate analytical development at Ascentage Pharma and with external contractors for new drug development
  • Coordinate development of analytical and control tests for API, starting materials, process intermediates, and finished drug products at Ascentage Pharma and through CROs
  • Organize and conduct INDs and NDA filings, and Annual Reports
  • Handle audit/inspection by regulatory agency such as FDA, EMA, and CFDA
  • Be responsible for increasing the operation efficiency and productivity while improving the current quality systems and ensuring full compliance to all applicable regulatory standards within the Analytical Center

Minimum Requirements:
  • M.S. or Ph.D. in Analytical Chemistry or related field.
  • At least 10 years above working experience in Analytical field in Pharma Industry.
  • Familiar with requirements of the FDA, EMA and CFDA regulations, ICH guidelines

Location: Suzhou or Taizhou, Jiangsu Province

To apply, please send a cover letter and C.V. to moc.a1544542474mrahp1544542474egatn1544542474ecsa@1544542474RH1544542474.


Business Development

The Business Development Manager will contribute to the successful execution of Ascentage’s corporate strategy by providing support for external partnership. The candidate is expected to collaborate with the Research & Development, Finance, Legal and other teams to establish and maintain successful relationships with partners for accessing innovation that enable drug discovery through collaboration. The candidate is expected to establish strategic relationships with external corporate entities to source, evaluate and negotiate partnerships to access innovative technologies in support of Ascentage’s overall growth strategy.

Main Responsibilities:
  • Work closely with Research and Development at Ascentage to develop, implement and manage corporate R&D strategy
  • Coordinate communications between Ascentage’s R&D and external partners throughout the entire opportunity sourcing, evaluation, diligence and negotiation process
  • Develop and execute contracts in close collaboration with Legal, Compliance, and Finance teams
  • Support project management of on-going partnerships

Minimum Requirements:
  • Doctorate or Master degree with at least 3 years of Business Development and/or drug research and development experience or Bachelor’s degree with 5 years of Business Development and/or drug research and development experience. Majors include but not limited to Pharmaceutical Sciences, Life Sciences, Biotechnology, Clinical Medicine, Pharmacology, etc. Additional credentials in Finance, Accounting or Law highly preferred
  • Solid knowledge in oncology therapeutic area. Familiar with novel molecular targets currently in early-stage development worldwide
  • Experience in search and evaluation of innovative therapeutic assets, ideally small molecules
  • Strong communication skills across different functions within the organization, including Competitive Intelligence, Legal, Clinical, CMC, and Finance
  • The ability to work independently as well as coordinate across functions

Location: Flexible locations in the United States or China (Shanghai or Suzhou preferred)

To apply, please send a cover letter and C.V. to moc.a1544542474mrahp1544542474egatn1544542474ecsa@1544542474RH1544542474.

The Business Development Analyst will contribute to the successful execution and implementation of Ascentage’s corporate strategy by providing support for external partnership. The staff member’s primary focus will be on supporting and optimizing internal functionality within Business Development team. She/he will provide support on deal tracking, research and analysis; coordinate cross-functional communication with Research & Development, Finance, Legal and other teams to establish and maintain successful relationships with partners for accessing innovation that enable drug discovery through collaboration.

Main Responsibilities:
  • Support communications between Ascentage’s R&D and external partners throughout the entire deal process
  • Support deal tracking, research and analysis through various sources (public domain and database)
  • Support internal organizational activities of Business Development team

Minimum Requirements:
  • Master degree with or without prior Business Development and/or drug research and development experience or Bachelor’s degree with 1-2 years of Business Development and/or drug research and development experience. Majors include but not limited to Pharmaceutical Sciences, Life Sciences, Biotechnology, Clinical Medicine, Pharmacology, etc.
  • Strong capabilities in data collection and analysis
  • Proficient in Excel and PowerPoint

Location: Shanghai or Suzhou preferred

To apply, please send a cover letter and C.V. to moc.a1544542474mrahp1544542474egatn1544542474ecsa@1544542474RH1544542474.