- Ensure required regulatory support for dMed and its clients, implement drug registration strategy plan or operational service as per project and/or customer’s needs
1.Provide regulatory related guidance and service regarding design, development, evaluation or marketing of the product to the project teams to ensure compliant with relevant guidelines and governmental regulations.
2.Work with clients, internal teams and key stakeholders for preliminary registration planning based on drug’s nature, clinical indication, intended clinical trial regime, data from previous studies, and the jurisdiction(s) the sponsor intends to submit.
3.Track and monitor the implementation process: all the way through IND/CTA/NDA submissions. Review of exception and needs of customer and follow up with customer per projects.
4.Lead or Support the development or implementation of clinical trial protocols, preparation and submission of regulatory agency applications, dossier, or correspondence per project and business needs.
5.Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
6.Review regulatory agency submission materials, marketing literature or user manuals, etc. per project needs to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
7.Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats; Or evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.
- Establish and maintain good relationship with regulatory authorities and industry associations for business support and understand key regulatory changes
1.Monitor changes of industry related regulations, support to develop and implement regulatory strategy for the responsible projects or provide needed consultation
2.Maintain Health Authority and industry association interaction on behalf of dMed for regulatory strategy assessment, have updated knowledge and understanding on regulatory changes and trends, enhance dMed exposure and contribution.
- Contribute to dMed internal regulatory intelligence development, documentation system and training program, consultation and support to business opportunities, etc.
1.Establish and maintain internal regulatory intelligence pool as necessary; Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
2.Communicate regulatory information to the company and relevant departments or clients, and ensure that information is interpreted correctly.
3.Establish and ensure operational process, training programs, and systems are appropriately and effectively support compliance to regulatory requirements changes as well as applicable quality standards.
4.Support activities such as audits, regulatory inspections, etc.
5.Develop, update and maintain regulatory affairs relevant SOPs, ensure SOPs training completion; Maintain accurate documentation of SOPs and other training files.
- Bachelor or master degree in a life or medical sciences or relevant scientific background.
- At least 5 years of relevant pharmaceutical industry experience, and prior regulatory affair or submission related work experience with understanding of GXP requirements and solid knowledge of ICH guidelines.
- Experience in supporting new product plan, registration trials, regulatory interactions will be a plus.
备注： ‘职位年薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。