Senior Manager, Regulatory Affairs China Immunology
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Beijing ChinaJob Description:
Job Summary
We are seeking a Senior Manager in the Immunology TA of China Regulatory Affairs to lead end-to-end regulatory strategy and execution for new asset development and lifecycle management in China. This role will lead China regulatory interactions drive highquality submissions and approvals monitor changes to regulatory requirements and standards identify and mitigate regulatory risks and partner closely with R&D and commercial teams to enable successful drug development registration and commercial continuity in China.
Key Responsibilities:
Develop and implement optimal regulatory strategies for new product development and life cycle management that align with global regional and China objectives.
Prepare and deliver high-quality on-time regulatory submissions and secure approvals for CTAs NDAs/BLAs variations renewals etc. according to China requirements.
Serve as the primary liaison with China regulatory agencies; Lead health authority interactions in China including briefing books face-to-face or virtual meetings and drive timely effective responses to health authority queries.
- Monitor and interpret changes in drug registration related regulations and guidelines in China; assess their impacts on existing products and future development programs.
Identify regulatory risks and partner with cross-functional teams to develop and implement mitigation plans.
Communicate regulatory strategy status timelines risks and business implications clearly to cross functional stakeholders.
- Collaborate closely with R&D QA/Compliance Supply Chain and Commercial teams to support drug development registration launch and lifecycle activities.
Provide regulatory input on new regulations and guidelines and advise on their impact to drug development product launch and business continuity.
Ensure regulatory activities in compliance with applicable regulations company policies and RA department SOPs.
Qualifications & Competencies
Masters degree or above in chemistry pharmaceutics biology or a related life-science discipline.
More than 5 years of regulatory affairs experience in a multinational pharmaceutical company.
Experience in pharmaceutical R&D and leading regulatory strategy development for new assets. Strong familiarity with China regulatory systems and requirements.
Growth mindset with strong collaboration communication and influencing skills in a matrix organization. Demonstrated leadership and learning agility.
Excellent English communication skills (spoken and written); proficient computer skills and strong story telling/presentation abilities.
Required Skills:
Preferred Skills:
Analytical Reasoning Business Writing Fact-Based Decision Making Industry Analysis Legal Support Mentorship Organizing Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments Risk Compliance Strategic Thinking Technical CredibilityRequired Experience:
Senior Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
