Position Title:Manager, Regulatory Affairs CMC
Department:Regulatory Affairs & Strategy
Location:Beijing or Shanghai

Position Summary

Responsible for the regulatory affairs, ensure required CMC support and submissions support for dMed and its clients, implementing drug registration operation service support as per project needs, such as IND, NDA, lifecycle submissions and healthy authority query response, as well as the submissions-related activity. Maintain good relationship with regulatory authorities for business support. Keep apprised of regulatory developments and understanding key regulatory changes locally and globally. Contributing to dMed internal regulatory intelligence development, documentation system and training program, supporting business opportunities, etc.

Key Responsibilities

Ensure required CMC support for dMed and its clients.

l Support regulatory CMC dossiers preparation and review for registration.

l Quality of project documentation and presentations: Documentation of high quality (e.g. meeting agenda and minutes, project plans, etc.).

l Timeliness of deliverables: No delays in approvals of local clinical studies, local registration dossiers or variations due to late or inadequate documentation on matters within CMC control.

l Reliable, timely and accurate information / communication about project specific issues within Reg CMC and to key stakeholders within Tech Ops, DRA and TRD as appropriate, changes in project status communicated as required.

l Ensure that CMC regulatory documentation follows dMed guidelines and meets regulatory guidelines, as appropriate (e.g. measured by approval of CMC documentation, and no non-approvals due to CMC issues under our control).

l Provide regulatory evaluation and advice for China on time and of high quality (change control, etc.); regulatory compliance met.

l Positive customer feedback.

Establish and maintain good relationship with regulatory authorities and industry associations for business support and understand key regulatory changes

l Monitor changes of industry related regulations, support to develop and implement regulatory strategy for the responsible projects or provide needed consultation.

l 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.

Ensure required regulatory support for dMed and its clients, implement drug registration operational service as per project and/or customer’s needs

l 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.

l 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.

l 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.

l Review regulatory agency submission materials, marketing literature or user manuals, etc. per project needs to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards

l Publish document submissions either in hardcopy or electronic formats;

l Interact with clients, relevant key functions/business units internally and externally to facilitate the project development.

l 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.

Contribute to dMed internal regulatory intelligence development, documentation system and training program, consultation and support to business opportunities, etc.

l Establish and maintain internal regulatory intelligence pool as necessary; Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.

l Communicate regulatory information to the company and relevant departments or clients, and ensure that information is interpreted correctly.

l 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.

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

l Develop, update and maintain regulatory affairs relevant SOPs, ensure SOPs training completion; Maintain accurate documentation of SOPs and other training files.

Education and Key Competency Requirements

Professional Experience & Education Requirement

l Requires of Ph.D., Pharm D, with 2-4 years pharmaceutical industry experience (preferably within development functions), or MS degree in chemistry or biology or other life sciences area with 6 years pharmaceutical industry experience or BS degree in life sciences with 8 years pharmaceutical industry experience.

Key Competency Requirement

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

l Effective project management skill.

l Good oral and written communication skills and well developed interpersonal skills. Good analytical skills and good project management skills.

l Possess sound judgment and decision-making capabilities in technical, business, and regulatory arenas.

l Good analytical and issue identification abilities, and attention to detail.

l Creative problem solver and keen ability to address current and anticipated issues.

l Good teamwork spirit and positive working attitude.

Apply for the position

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