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:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Essential Job Duties and Responsibilities

• Lead the development of regulatory strategies for R& D portfolios related to assigned projects, ensuring alignment with overall business objectives.
• Serve as the Regulatory lead, providing strategic regulatory input to China and global compound teams. Responsible for the execution of CTA and BLA filings and so on, with a particular focus on large molecule products. Lead the consultations with relevant Health Authorities.
• Act as the RA representative to offer regulatory expertise to local product teams and cross-functional teams to ensure compliance and strategic alignment.
• Ensure timely submission of regulatory filings and address any queries from Health Authorities promptly and effectively.
• Demonstrate keen awareness of Chinese regulatory policies and proactively integrate these insights into the regulatory strategy for applications. Adapt strategies as needed to align with evolving regulations and guidelines.
• Establish and maintain strong relationships with regulatory authorities and key stakeholders within the local, regional, and global organization to facilitate effective communication and collaboration.

Stay updated on regulatory requirements and guidelines specific to large molecules, ensuring that all applications and submissions meet the necessary standards and regulations.

Summary of Job Responsibilities:

Dimensions of Job:

Strategic Influence:

• Develop and implement regulatory strategies that align with the business goals of the Neuroscience Therapeutic Area.
• Influence internal stakeholders and cross-functional teams to ensure regulatory considerations are integrated into project planning and execution.

Regulatory Expertise:

• Serve as the expert on regulatory requirements and guidelines specific to neuroscience products, including large molecules.
• Provide guidance on regulatory pathways and risk assessments to support product development and commercialization.

Project Leadership:

• Lead regulatory activities for multiple projects within the Neuroscience TA, ensuring timely and compliant submissions to regulatory authorities.
• Manage complex projects and prioritize tasks effectively to meet deadlines and achieve regulatory milestones.

Stakeholder Engagement:

• Build and maintain strong relationships with regulatory authorities, to facilitate successful interactions and negotiations.
• Collaborate with global, regional, and local teams to ensure alignment and leverage best practices.
• Promote teamwork and collaboration within the regulatory affairs team and across other functions.

Regulatory Intelligence:

• Monitor and interpret changes in the regulatory environment, particularly in China, and assess their impact on the Neuroscience TA.
• Proactively adapt regulatory strategies to address new challenges and opportunities.

Operational Excellence:

• Ensure high-quality regulatory submissions and responses to health authority queries, maintaining compliance with all relevant regulations and standards.
• Implement process improvements to enhance the efficiency and effectiveness of regulatory operations.

Principal Accountabilities of Job:

Regulatory Strategy Development:

• Develop and execute comprehensive regulatory strategies for neuroscience projects, ensuring alignment with corporate objectives and compliance with global and local regulatory requirements.

Submission Management:

• Lead the preparation, submission, and management of regulatory filings, including CTAs, BLAs, and supplemental applications etc. with a focus on large molecule products.

Regulatory Consultation and Negotiation:

• Prepare for and lead consultations with regulatory authorities, to facilitate successful product approvals and lifecycle management.

Cross-Functional Collaboration:

• Collaborate with cross-functional local and global teams, including R& D, clinical, and commercial teams, to ensure regulatory considerations are integrated into product development and marketing plans.

Regulatory Compliance and Risk Management:

• Ensure all regulatory activities comply with applicable laws, regulations, and guidelines. Identify and mitigate regulatory risks throughout the product lifecycle.

Stakeholder Relationship Management:

• Build and maintain effective relationships with regulatory authorities and key stakeholders within the organization to support regulatory objectives and facilitate communication.

Regulatory Intelligence and Adaptation:

• Stay informed about changes in the regulatory environment, particularly in China, and assess their impact on the Neuroscience TA. Adapt strategies proactively to address new regulatory challenges.

Key Performance Measures:

Timeliness of Submissions: Percentage of regulatory submissions (e.g., CTAs, BLAs) delivered on or ahead of schedule.

Approval Success Rate: Rate of successful approvals for regulatory submissions, reflecting the quality and compliance of applications.

Regulatory Query Response Time: Average time taken to respond to queries from regulatory authorities, ensuring prompt and effective communication.

Regulatory Strategy Implementation: Effectiveness in developing and executing regulatory strategies that align with project timelines and business objectives.

Stakeholder Satisfaction: Feedback from internal and external stakeholders regarding the quality of regulatory support and communication.

Regulatory Intelligence Utilization: Ability to anticipate and adapt to changes in the regulatory environment, ensuring strategies remain current and effective. Cross-Functional Collaboration: Effectiveness in working with cross-functional teams, as measured by the successful integration of regulatory considerations into project plans.

Qualifications & Competencies

• Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred
• Minimum of 5-8 years regulatory affair experience in a multinational pharmaceutical company with a focus on large molecule products, have experience in initial BLA application.
• Excellent verbal and written English communication skills, with the ability to clearly convey complex regulatory information to diverse audiences. Excellent slides preparation and good presentation skill.
• In-depth knowledge of regulatory environment, regulations and guidelines. Experience in HA interactions and pharmaceutical product registration, inspection/QC testing and so on.
• Ability to establish and maintain strong relationships with regulatory authorities and key stakeholders within the organization. Capacity to adapt to changing regulatory landscapes and manage multiple priorities in a fast-paced environment.
• Ensure compliance and comply internal and external requirements and procedures.
• Ability to communicate regulatory plan and strategy to cross functions. Experience in working in project teams and/or a matrix organization
• Proficiency in verbal and written English; good computer skill, good presentation skill.