Regulatory Affairs Sr. Manager

Regulatory Affairs Sr. Manager - China

Reporting to: Head of Regulatory Strategy, China RA

Based in: Beijing

Job Description:

• Develop China registration strategy and implement regulatory submissions (CTN, MAA, variations) for products within Amgen’s portfolio in compliance with corporate standards and local regulatory requirements.
• Develop HA communication strategy for critical issues, apply for & organize HA meeting and finalize the meeting minutes.
• Undertake interactions and negotiations with Regulatory Authorities, to optimize regulatory approvals.
• Manage registration submissions for supplemental application, license renewal and variations of marketed products and ensure optimal regulatory support to product lifecycle management for business objectives.
• Ensure successful implementation of Regulatory Affairs and high quality of filing dossier.
• Establish and maintain direct contact with Global / regional regulatory team for information sharing and ensuring timely support.
• Closely 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.
• Support for Therapeutic Areas/Scientific Affairs activities.
• Where applicable, oversee external vendor/contractor relationships.

Knowledge and Skills

• Profound knowledge of pharmaceutical business, worldwide drug development and regulatory processes, expertise of international and national regulatory guidelines.
• Ability to effectively manage interactions with internal and external stakeholders for ensuring optimal cooperation.
• Understanding of market access needs and implementation of appropriate measures for health care purposes.
• Strong interpersonal skills and ability to interface effectively with company local relevant functions and global regulatory team.
• Ability to anticipate and facilitate issue resolution to meet local registration requirements.
• High leadership skills with both practical and short/long term strategic vision; ability to build relationships; strong team leader as well as team player.
• Demonstrates 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.

• A good blend of strategic and analytical thinking; innovative personality; able to see the bigger picture.
• Scientific / Technical Excellence
• Communication Skills: Oral and Written
• Team Work and willing sharing

Basic Qualifications:

• Doctorate degree with more than 5 years directly related working experience

OR

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

OR

• Bachelor’s degree and 12 years of directly related experience

Preferred Qualifications:

• Experience in MNCs,
• Experience in biologics
• Experience in medical devices registration field
• Multi-lingual