Regulatory Affairs

Main Responsibilities:
  • Complete trainings for GCP and SOPs as required
  • Planning for study human resource, budget, number of investigational products and study materials.
  • Provide clinical operation inputs for study protocol design and review.
  • Lead the development of study operation documents (e.g., ICF, memory aids, study agreement, recruitment plan, monitoring plan, SDV plan, etc.) and provide clinical inputs for other study documents (e.g., CRF template, data management plan, etc.).
  • Prepare and lead study feasibility, site selection and the delivery of approved study protocol.
  • Plan and lead the organization of national investigator/monitor meetings to ensure appropriate study related trainings for site staff and monitors.
  • Regular progress review in study team; serve as mentors for CRAs, and support team members to solve identified issues to ensure the delivery on time and to high quality and ensure safety reporting complying with regulations.
  • Update study management electronic tools/platforms if applicable.
  • Timely report to line manager and management team on study progress, identified recruitment/quality issues and budget control.
  • Work with QC personnel to support the activities associated with audits; work with QA and QC personnel and contribute to regulatory inspection preparation team as required; develop, perform, and follow up corrective and preventive actions for inspection/audit/QC checking findings.
  • Work with team members and internal stakeholders to share knowledge, best practices, and study experience.
  • Provide clinical operation inputs for study data review.
  • Coordinate and/or contribute to timely delivery of operations components of submissions to regulatory authorities, e.g., annual reports and CSR.

Minimum Requirements:
  • Bachelor degree or above of medical science or related field, desirable: medical/pharmacological/nursing background.
  • at least 4-year working experience as CRA in pharmaceutical clinical research, experience in project management preferred.
  • Project management skills (including study scope, timeline, budget, resource management and use of associated tools).
  • Ability to lead cross-function team, establish and maintain excellent working relationship with PI, relevant site staff and internal stakeholders.
  • High quality standard is applied.
  • Full understanding of GCP.
  • Familiar with company SOPs.
  • Demonstrate knowledge of clinical study and drug development process, and expertise in risk management and contingency planning.

Location: Shanghai

To apply, please send a cover letter and C.V. to .

Main Responsibilities:
  • Reviews and provides feedback on protocol, CRF, SAP and other study-related documents to ensure all programming requirements are met.
  • Creates SDTM, ADaM datasets following CDISC compatible standards.
  • Performs statistical programming for statistical deliverables.
  • Performs ad-hoc and exploratory analysis as requested.
  • Performs quality control for statistical programming.
  • Prepares the eCTD package for NDA submission.
  • Responsible for timely and quality programming documentation at study level.

Minimum Requirements:
  • Bachelor or master’s degree in statistics, biostatistics, mathematics, epidemiology, computer science, or relevant field.
  • Good SAS programming skill is required.
  • Solid knowledge in CDISC standards and FDA/EMA/ICH guidelines is preferred.
  • Effective English verbal and written communication skills.
  • Ability to work effectively in a multi-cultural context as a good team member.

Location: Shanghai, Guangzhou, or Suzhou

To apply, please send a cover letter and C.V. to .

Main Responsibilities:
  • Create and implement the Data Management Plans (DMP) to ensure data completeness and accuracy.
  • Perform data cleaning activities including discrepancy management (review of errors from electronic checks).
  • Ensure timely set-up of clinical data acquisition and management tools and data validation.
  • Maintain study tracking to ensure timely CRF retrieval, data entry and data cleaning activities.
  • Ensure integrity of clinical data and update database by issuing and resolving DCFs as necessary.
  • Set-up and test data review listings to verify the quality and completeness of data as specified in DMP.
  • Reconcile the patient database with the Serious Adverse Event database.
  • Document all efforts of data management and file all responsible documents.

Minimum Requirements:
  • Bachelor or master’s degree in medical, statistics, epidemiology, computer science, or relevant field.
  • Highly efficient with excellent communication skills.
  • Solid knowledge in CDISC standards and FDA/EMA/ICH guidelines is preferred.
  • Effective English verbal and written communication skills.
  • Ability to work effectively in a multi-cultural context as a good team member.

Location: Beijing, Shanghai, Guangzhou, or Suzhou

To apply, please send a cover letter and C.V. to .

Main Responsibilities:
  • Through regional potential analysis, select potential KOLs and quickly establish cooperative relationships, and clearly formulate regional goal.
  • Through effective academic visits and frequency of visits, brand information can be correctly transmitted, and customer brand awareness and concepts can be established.
  • Integrate regional market brand strategies and plans to cooperate with the team with effective strategies and activity plans.
  • Timely collection and feedback of clinical needs and competing product information.
  • Reasonable management of regional time and sales budget.
  • Efficiently complete the daily sales management reports required by the company.
  • Complete sales targets under compliance.

Minimum Requirements:
  • Possess professional disease knowledge, product knowledge and sales skills.
  • Good business planning and implementation capabilities.
  • Have a high degree of market sensitivity and innovation are required.
  • Good sense of teamwork.
  • Strong drive and positive pursuit of results.
  • Good pressure resistance ability.

To apply, please send a cover letter and C.V. to .

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 .

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 .

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 .


Clinical Development

Main Responsibilities:
  • Complete trainings for GCP and SOPs as required.
  • Prepare, conduct, and report on pre-study visit evaluation, support project manager (PM) to identify potential investigators and site staff/facility qualification.
  • Support PM for document master templates development in the studies (e.g., agreement, ICF, other operation document master template, etc.).
  • Obtain and maintain essential documentation in compliance with ICH-GCP, Chinese GCP Chinese related regulations and SOPs of the company during the study period, timely study document distribution to designated archivist for archiving.
  • Negotiate study agreement with investigators, Co-ordinate shipment and review dispensing, and storage of investigational products (IP) and other study related materials at responsible site; provide study related trainings for site staff delegated no later than initiation. Prepare, conduct, and report on site initiation.
  • During study period, track subject recruitment, compliance with regulations and SOPs, and data quality status of responsible sites timely; prepare, conduct and report site monitoring visits according monitoring plan, review inform consent forms and IEC documents, review safety reporting, perform source data verification and review data clarification, review IP storage condition and accountability; providing study related re-training for site staff if applicable; follow up solution progress of issues being identified during monitoring.
  • Attend study review meetings/monitor meetings and training as required; organize protocol review meeting at study site; support PM/delegate for national investigator meeting organization.
  • Track investigator payment and documentation for responsible sites.
  • Prepare for and participate regulatory inspection, audit or QC checking at responsible sites, respond to findings, prepare, and implement action plan to improve compliance if needed under line manager’s coaching.
  • Prepare, conduct, and report on study closure site; resolve outstanding queries and identified monitoring issues, retrieve CRFs; ensure regulatory documents available and updated; ensure IP and study materials accountability, return and disposal if required; ensure final payment processed to investigators; ensure study report distributed to PI for EC submission.
  • Serve as mentor to other CRAs of the study team in conjunction with PM.
  • Perform other tasks assigned by supervisor including being a lead CRA when required to support PM’s work.

Minimum Requirements:
  • Bachelor’s degree or above of medical science or related field, desirable: medical/pharmacological/nursing background.
  • At least 3 years working as CRA in pharmaceutical clinical research.
  • Advanced monitoring skills, including study start-up, ongoing stage, and study closure.
  • Full understanding of GCP.
  • Familiar with company SOPs.
  • Able to establish and maintain good working relationship with study site staff and study team members.
  • Project management skills.

Location: Beijing, Shanghai, Guangzhou, or Wuhan

To apply, please send a cover letter and C.V. to .

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 .

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 .

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 .

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 .

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 .


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 .