Sr Mgr, Regulatory Affairs

Job Summary:

nDevelop China registration strategy and implement regulatory submissions (China IND/CTN etc.) for products within Amgen’s portfolio in compliance with corporate standards and local regulatory requirements.

nDevelop HA communication strategy for critical issues, apply for & organize HA meeting and finalize the meeting minutes.

nUndertake interactions and negotiations with Regulatory Authorities, to optimize regulatory approvals.

nManage registration submissions for supplemental application, license renewal and variations of marketed products and ensure optimal regulatory support to product lifecycle management for business objectives.

nEnsure successful implementation of Regulatory Affairs and high quality of filing dossier.

nEstablish and maintain direct contact with Global / regional regulatory team for information sharing and ensuring timely support.

nClosely follow up regulation changes and analyze/predict its impact on company registration strategies.
Contribute to company systems development, support China RA team to develop or enhance regulatory related SOPs, management systems, working procedures, etc. to improve team operational efficiency.

nSupport for Therapeu8tic Areas/Scientific Affairs activities.

nWhere applicable, oversee external vendor/contractor relationships.

Knowledge and Skills

nProfound knowledge of pharmaceutical business, worldwide drug development and regulatory processes, expertise of international and national regulatory guidelines.

nAbility to effectively manage interactions with internal and external stakeholders for ensuring optimal cooperation.

nUnderstanding of market access needs and implementation of appropriate measures for health care purposes.

nStrong interpersonal skills and ability to interface effectively with company local relevant functions and global regulatory team.

nAbility to anticipate and facilitate issue resolution to meet local registration requirements.

nHigh leadership skills with both practical and short/long term strategic vision; ability to build relationships; strong team leader as well as team player.

nDemonstrates and encourages ownership and responsibility; drive/motivation - has a “can-do” attitude and is committed to delivering high quality results and strives for continuous improvement.

nA good blend of strategic and analytical thinking; innovative personality; able to see the bigger picture.

nScientific / Technical Excellence

nCommunication Skills: Oral and Written

nTeam Work and willing sharing

Basic Qualifications:

nDoctorate degree with more than 5 years directly related working experience

OR

nMaster’s degree and more than 8 years of directly related experience

OR

nBachelor’s degree and 12 years of directly related experience

Preferred Qualifications:

nExperience in MNCs,

nExperience in biologics

nExperience in medical devices registration field

nMulti-lingual