• 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.

• 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.

• 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.

• 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.

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.

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.

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.

Sr. Regulatory Operations Manager (Rockville, MD) (multiple positions).  Provide regulatory and technical expertise related to submission readiness of clinical, non-clinical and chemistry manufacturing control (CMC) documents for developing new drugs and medical devices and/or combination products. Coordinate preparation of regulatory documents, including Investigational New Drug (IND)/New Drug Application (NDA), Clinical Trial Applications, Marketing Authorization Application (MAA), Supplements/Amendments, and Variations.  Establish the eCTD (electronic Common Technical Document) publishing systems, processes, ESG gateway account for FDA submissions and creation of submission processes for other health authorities such as Health Canada, EMA, Australia, etc. Review FDA and other health authority guidelines to prepare, compile and submit dossiers for review and approval of investigational drugs.  Perform report and sequence level publishing and submission-ready activities following internal and regulatory requirements. Ensure quality control of draft and final published submission output to ensure compliance to U.S. regulatory agency standards and requirements for electronic submissions.  Maintain all regulatory requests following the company’s standard operating procedures. Maintain working knowledge of global health authorities’ publishing standards (U.S. FDA, EMA). Coordinate electronic document management workflows for regulatory eCTD submission. Telecommuting Permitted. Requires a Master’s degree or foreign equivalent in Biology, Pharmacology, Chemistry, or a related field, and two (2) years of experience in the job offered or a related regulatory affairs position implementing eCTD and document publishing tools. Must have two (2) years of experience with each: 1) Reviewing, compiling, publishing and filing eCTD submissions for INDs, NDAs, and Supplements/Amendments  to FDA and other health authorities; 2) Implementing FDA eCTD specification standards for documents authored internally; 3) Identifying and  implementing eCTD and document publishing tools for establishing regulatory operation within the company; 4) Managing multiple regulatory publishing activities for various application and submission types  which are in various clinical development stages (Phase I, II and III); 5)  Leveraging systems such as Share Point, SAS  tools, and Veeva systems for authoring and submitting regulatory documents as per health authority requirements.  Send resume with cover letter to Ascentage Pharma Group Inc., Attn: J. Gilmore (ref#TV2021) 800 King Blvd., Suite 300, Rockville, MD 20850.  No calls. EOE

• 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.

• 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

• 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

• 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

• 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

• 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

• 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