Regulatory Affairs Manager, Operations

About Human Pharmaceutical Business

With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.

This position belongs to regulatory affairs department, serving The Chinese Market which encompasses China mainland, Taiwan, Hongkong.

This role requires a detail-oriented professional who can oversee all regulatory affairs and quality assurance activities, ensuring compliance with local and international regulations.

This role drives continuous improvement in regulatory affairs.

Tasks & responsibilities

-Ensure quality management system is well established and implemented in TCM RA.

-Identifies the needs for best practices, processes, SOPs, tools, training sessions and designs related activities. Build systemic processes.

-Collaborate with stakeholders and coordinate with internal teams to ensure regulatory compliance throughout the product lifecycle.

-Provide training and guidance to the team on regulatory and quality matters.

-Participate in continuous improvement initiatives to enhance compliance and streamline processes.

-Ensure TCM RA projects are well planned and status information is systemically tracked.

-Give sufficient operational support to regulatory submissions etc. as needed.

Requirements

-Strong learning ability.

-Good project management skill and experience. Be able to work with a keen sense of urgency and priority.

-Good personalities with team spirit.

-Good interpersonal and communication skills.

-Bachelor degree or above, major in pharmaceutics is preferred.

-At least 7 years related working experiences in regulatory affairs or GxP quality area.