Regulatory Affairs
缔脉生物医药科技有限公司ShanghaiUpdate time: May 15,2019
Job Description

Position Title: Regulatory Affairs, Senior Specialist/ Specialist

Position Summary

Responsible for the regulatory affairs, submissions support for dMed and its clients, relevant regulatory operation service support as per project needs, such as HA consultation/communication, IND & NDA or lifecycle submissions document preparation, and support the preparation for healthy authority query response. Maintain good relationship with regulatory authorities for business support. Keep apprised of regulatory developments and understanding key regulatory environment update locally and globally. Support internal regulatory intelligence development, documentation system and training program, supporting business opportunities, etc.

Key Responsibilities

I. Carry out regulatory operational service as per project and/or customer’s needs

1. Work with clients, internal teams and key stakeholders for registration / project 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.

2. Implement the registration / submission plan according to timeline per project or customer needs, such as information collection, material preparation, cross-function coordination, etc.

3. Follow through the regulatory process of IND/CTA/NDA submissions. track timeline, and review expectation and needs of customer and follow up with customer per projects.

4. Respond to questions or information request in timely manner, and ensure seamless collaboration cross functionally to prevent from delay.

5. Provide hands-on regulatory service delivery by supporting the implementation of clinical trial protocols, preparation and submission of regulatory agency applications, dossier, or correspondence per project and business needs.

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. Provide report on regulatory process and project progress.

8. Contribute to the establishment of procedures or systems for publishing document submissions either in hardcopy or electronic formats; Or support to evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.

9. Support to develop and implement or monitor regulatory related complaint or issue processing mechanism to ensure effective and timely resolution of all compliant or issue investigations.

10. Be responsible for regulatory document and raw material archiving and maintenance.

II. Establish and maintain good relationship with regulatory authorities for business support and understand key regulatory updates.

1. Develop and have updated knowledge and understanding on industry related regulations or regulatory changes or trends, and apply the knowledge in the service delivery and projects.

2. Support Health Authority and industry association events or interactions on behalf of dMed to enhance company exposure and contribution to the industry.

III.Contribute to dMed internal regulatory intelligence development, documentation system and quality assurance system and process to ensure regulatory compliance.

1. Track and collect regulatory or industry related information and changes to support internal regulatory intelligence pool establishment and maintenance; Monitor emerging trends regarding industry regulations to evaluate potential impacts on organizational processes.

2. Contribute to communication and education of regulatory information to relevant departments or clients and ensure that information is interpreted correctly.

3. Execute or participate operational process, training programs, to ensure compliance to regulatory requirements as well as applicable quality standards.

4. Support activities such as audits, regulatory inspections, etc.

5. Maintain regulatory affairs relevant SOPs, ensure SOPs training completion; Maintain accurate documentation of SOPs and other training files.

Education and Key Competency Requirements

I. Professional Experience & Education Requirement

1. Bachelor or Master’s degree in a life or medical sciences or relevant scientific background.

2. At least 3 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.

3. Experience in supporting new product plan (Prior Biologics and Oncology TA), registration trials, regulatory interactions will be a plus.

II.Key Competency Requirement

1. Solid knowledge of ICH Guidelines, local regulatory agency and Ethics Committee regulations and GXPs as related to pharmaceutical, biologics, biosimilar and medical device, including, but not limited in regulatory requirements for the conduct of clinical development programs.

2. Strong understanding of key regulations and submission requirements in US, China and other regions, and ability to apply to real case.

3. Effective project management skill and strong execution capability.

备注: ‘职位月薪’ 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。

职能类别: 生物工程/生物制药




Get email alerts for the latest"Regulatory Affairs jobs in Shanghai"