About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
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Position Summary
The Senior Regulatory Affairs Manager is responsible for developing and executing regulatory strategies to support the registration, approval, lifecycle management, and commercialization of oncology products in China. This role serves as a key regulatory partner to global and local cross-functional teams, ensuring compliance with National Medical Products Administration (NMPA) requirements while supporting business objectives and patient access to innovative therapies.
The position requires strong regulatory expertise, strategic thinking, stakeholder management, and leadership capabilities to successfully navigate an evolving regulatory environment and drive organizational success.
Key Responsibilities
Regulatory Strategy
- ✓Develop and implement regulatory strategies for assigned oncology products to achieve business objectives and ensure timely market access in China.
- ✓Provide regulatory leadership and strategic guidance throughout product development, registration, and commercialization.
Product Registration and Approval
- ✓Lead preparation, compilation, review, and submission of regulatory applications to NMPA and other relevant authorities.
- ✓Coordinate cross-functional activities required to support product registrations and approvals.
- ✓Manage regulatory agency interactions and address questions arising during the review process.
Lifecycle Management
- ✓Ensure timely execution of all post-approval regulatory activities, including variations, renewals, labeling updates, and commitments.
- ✓Maintain product licenses and registrations in compliance with regulatory requirements.
Regulatory Intelligence and Policy
- ✓Monitor regulatory developments and assess their impact on company products and business operations.
- ✓Provide strategic recommendations regarding new regulations, guidelines, and industry trends.
- ✓Participate in industry associations and regulatory forums to influence policy discussions and maintain regulatory awareness.
Cross-Functional Partnership
- ✓Collaborate with global and local stakeholders to ensure alignment of regulatory strategies and business objectives.
- ✓Support product launch planning, portfolio management, and lifecycle optimization activities.
- ✓Provide regulatory expertise to commercial, medical, clinical, and market access teams.
Compliance and Quality Support
- ✓Partner with Quality Assurance to maintain regulatory compliance and quality system effectiveness.
- ✓Support audits, inspections, post-market surveillance activities, and corrective actions as required.
Reporting and Governance
- ✓Provide regular updates to senior management regarding regulatory project status, risks, and mitigation plans.
- ✓Maintain accurate regulatory records and ensure compliance with internal governance requirements.
Key Success Factors
- ✓Strong regulatory expertise and strategic mindset.
- ✓Excellent leadership and stakeholder management capabilities.
- ✓Ability to influence decisions in a matrix organization.
- ✓High level of integrity, accountability, and patient focus.
- ✓Proven ability to deliver results in a complex and evolving regulatory environment.
- ✓Commitment to continuous learning and professional development.
Education
- ✓Bachelor's degree or above in Pharmacy, Medicine, Pharmacology, Biology, Chemistry, Life Sciences, or a related scientific discipline.
- ✓Advanced degree (Master's, PharmD, PhD, or equivalent) preferred.
Experience
- ✓Minimum 10–15 years of regulatory affairs experience within the pharmaceutical industry.
- ✓Significant experience in China regulatory submissions, approvals, and lifecycle management.
- ✓Proven experience developing and implementing regulatory strategies for innovative pharmaceutical products.
- ✓Oncology therapeutic area experience strongly preferred.
- ✓Experience interacting directly with NMPA and other health authorities.
- ✓Experience working within a multinational pharmaceutical company environment is highly desirable.
- ✓Demonstrated experience leading complex cross-functional projects.
Technical Competencies
Regulatory Strategy & Execution
- ✓Develop and execute regulatory strategies to achieve timely product registrations and approvals in China.
- ✓Provide regulatory guidance throughout product development and commercialization.
- ✓Lead preparation, review, and submission of regulatory dossiers in compliance with NMPA requirements.
- ✓Support accelerated approval pathways, breakthrough therapy programs, and innovative product registrations where applicable.
Product Lifecycle Management
- ✓Manage regulatory maintenance activities including variations, renewals, labeling updates, and post-approval commitments.
- ✓Ensure ongoing compliance with applicable regulatory requirements.
- ✓Support launch readiness activities and commercial objectives.
Regulatory Intelligence
- ✓Monitor and interpret changes in Chinese and global regulatory regulations, guidelines, and policies.
- ✓Assess regulatory impact on business operations and development programs.
- ✓Communicate emerging regulatory risks and opportunities to stakeholders.
Health Authority Interactions
- ✓Lead regulatory interactions with NMPA and other regulatory agencies.
- ✓Prepare briefing packages and coordinate regulatory meetings.
- ✓Develop effective negotiation strategies to facilitate successful regulatory outcomes.
Quality and Compliance
- ✓Collaborate with Quality Assurance to maintain compliance with regulatory and quality system requirements.
- ✓Support inspections, audits, post-market surveillance activities, and product recalls when necessary.
- ✓Ensure regulatory documentation is maintained accurately and in accordance with company procedures.
Soft Skills & Leadership Competencies
Strategic Thinking & Business Acumen
- ✓Ability to align regulatory strategies with business priorities and product lifecycle objectives.
- ✓Strong understanding of the pharmaceutical industry, healthcare environment, and market access considerations.
- ✓Ability to identify opportunities and proactively address regulatory challenges.
Stakeholder Management & Influencing Skills
- ✓Demonstrated ability to influence and collaborate with stakeholders across functions and organizational levels.
- ✓Strong partnership skills with Medical Affairs, Clinical Development, Market Access, Commercial, Supply Chain, Manufacturing, Quality, and Global Regulatory teams.
- ✓Ability to build credibility and trusted relationships internally and externally.
Communication Skills
- ✓Excellent verbal and written communication skills in both English and Chinese.
- ✓Ability to communicate complex regulatory concepts clearly to technical and non-technical audiences.
- ✓Strong presentation, negotiation, and advocacy skills.
Collaboration & Enterprise Mindset
- ✓Strong cross-cultural and cross-functional collaboration skills.
- ✓Ability to balance local regulatory requirements with global business strategies.
- ✓Demonstrate a patient-centric mindset and commitment to ethical business practices.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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