Senior Manager, Regulatory Affairs China-Immunology

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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Beijing, China

Job Description:

Summary of Job Responsibilities:

• Develop regulatory strategies to support new products development and life cycle management.
• Deliver timely regulatory filings and approvals.
• Lead HA interactions, including consultation meetings and response to HA queries

Dimensions of Job:

• Develop optimized regulatory strategies for new products
• Deliver timely regulatory filings and approvals
• Provide regulatory insights to cross functional team in R&D and commerical for assigned projects
• Establish good relationship with HA and collaborate with key stakeholders in the local, regional and global organization
• Perform with high quality and compliance

Principal Accountabilities of Job:

• Develop and implement the optimal regulatory strategies for new products development and life cycle management.
• Deliver on-time and high-quality submissions and approvals for CTA, NDA/BLA, variation, renewal, etc.
• Serve as the primary liaison with regulatory agencies. Lead HA meetings and oversee their preparations. Drive the responses to HA queries and ensure effective communication with HA.
• Monitor and interpret changes in drug registration related regulations and guidelines, and assess their impacts on existing products and future developments..
• Identify the regulatory risks and work with cross functional team to generate mitigation plans.
• Ensure regulatory activities in compliance with the regulations, company rules and RA department’s SOPs.

Key Performance Measures:

• Time to Approval
• Regulatory Compliance Audits
• Stakeholder Satisfaction

Qualifications & Competencies

• Master’s degree or above in chemistry, pharmaceutics, biology or a related life-science discipline.
• > 5 years of regulatory affairs experience in a multinational pharmaceutical company.
• Strong lobby/negotiation capability and excellent communication skill; excellent leadership with team spirit; high learning ability and willing to work under high pressure.
• Have good communication with HA.
• Fluent English in verbal and written; good computer skill, good presentation skill.

Other Requirements

• Credo based behavior with regulatory compliance excellence.