Position Title:Regulatory Affairs, Senior Manager/Manager
Department:Regulatory Affairs & Strategy

Position Summary

Responsible for the regulatory affairs, submissions and consultation support for dMed and its clients, implementing drug registration strategy plan and relevant regulatory 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 regulatory support for dMed and its clients, implement drug registration strategy plan or operational service as per project and/or customer’s needs

  • 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.
  • 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.
  • 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.
  • 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.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Review regulatory agency submission materials, marketing literature or user manuals, etc. per project needs to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • 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.
  • Interact with clients, relevant key functions/business units internally and externally to facilitate the project development. Directly communicate (visiting host, holding TC and auditing, etc.) with national and international sponsors.
  • 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.
  • Establish and maintain good relationship with regulatory authorities and industry associations for business support and understand key regulatory changes

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

  • Establish and maintain internal regulatory intelligence pool as necessary; Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • Communicate regulatory information to the company and relevant departments or clients, and ensure that information is interpreted correctly.
  • 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.
  • Support activities such as audits, regulatory inspections, etc.
  • 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 Requirement
    Professional Experience & Education Requirement

  • 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.
  • Key Competency Requirement

  • Thorough knowledge of ICH Guidelines, local regulations and GXPs including, but not limited in regulatory requirements for the conduct of clinical development programs.
  • Strong understanding of key regulations and submission requirements in US, China and other regions, and ability to apply to real case
  • Effective project management skill.
  • Superb organization, communication s skills (oral and written in Chinese & English) and strong interpersonal skills to be able to effectively interact with customers, key stakeholders, health authorities, multidisciplinary groups as well as with vendors.
  • ossess sound judgment and decision-making capabilities in technical, business, and regulatory arenas
  • Good analytical and issue identification abilities, and attention to detail
  • Creative problem solver and keen ability to address current and anticipated issues
  • Regulatory writing experience will be a plus
  • Good teamwork spirit and positive working attitude
  • Able to travel per business needs
  • Apply for the position

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