At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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Job Description:

Job responsibilities:

• Execute regulatory submission for CTA & NDA/BLA & variation during clinical trials across TAs ensuring all activities following company procedures and local regulations.Collaborate with local project team, regional and global key stakeholders to prepare dossier and execute submission for CTA & NDA/BLA & variations during clinical trials.
• Execute QC testing related activities for CTA & NDA/BLA.Support HA query response.
• Coordinate internal discussion to update local procedures to meet global procedures and local regulations, guidelines if applicable.
• Develop and improve internal process for operation excellence.
• Actively lead or involve in review and revision of regulations, guidelines if applicable.
• Conduct related trainings for operation excellence.
• Credo based behavior with regulatory compliance.
• Good communication skill, risk management mindset and learning agility.

Qualifications & Competencies: ​

• Bachelor’s degree in chemistry, pharmaceutics, biology, or a related life-science discipline. Master’s degree is preferred.
• Minimum of 3 years’ experience in a multi-national pharmaceutical company.
• Strong oral & written communication skill; ability to work under pressure.
• In-depth knowledge of regulatory environment, regulations and guidelines.
• Experienced in working with cross-functional team for submission strategy and implementation.
• Proficiency in verbal and written English; good presentation skill, good computer skill.