JOB DESCRIPTION:
Primary Function/Primary Goals/Objectives:
- Secure existing drug products registration submission and approval on time to protect the business continuity.
- Ensure drug post-market regulatory compliance including formulation, label, leaflet, ingredient, change control, promotional materials, etc.
- Provide regulatory support to innovations/new projects, and regulatory training to internal stakeholders.
- External engagement with regulators, and industry association on new legislations monitoring regulation changes, and policy influence. Manage the internal legislation database.
Major Responsibilities:
- Manage the planning, preparation, and submission of drug product registration dossiers, ensuring they meet all relevant regulatory requirements and deadlines.
- Lead the development of robust regulatory strategies, integrating business goals and gaining consensus across local and divisional teams from various functions.
- Conduct regulatory assessments for change control management, evaluate potential impacts on submissions and registrations, and ensure continued compliance.
- Monitor emerging regulations and guidance; assess their impact on business and product portfolios and communicate critical updates internally.
- Review and approve packaging inserts, labels, and promotional materials for accuracy and compliance with internal SOPs and applicable regulations.
- Serve as a key point of contact for health authority interactions, including negotiations and follow-ups related to submissions and product compliance.
- Develop and deliver the drug regulatory knowledge training to internal functional teams, fostering regulatory awareness across the organization.
- Maintain and manage regulatory data and documentation in electronic systems, ensuring traceability and data integrity.
Supervisory/Management Responsibilities (Influence/Impact/Leadership):
- Serve as a regulatory subject matter expert, providing technical guidance and insights to cross-functional project teams.
- Collaborate effectively with internal stakeholders to drive regulatory activities and ensure alignment on project goals and timelines.
- Interface with various levels of management and external partners on regulatory matters, contributing to discussions and decision-making.
- Perform work independently, demonstrating accountability and sound judgment in managing routine and complex regulatory tasks.
Education:
- Bachelor's degree or above in pharmacy, chemistry, biology, or related life sciences is required. An advanced degree is preferred.
Background/Skills/Knowledge:
- Minimum of 5 years of experience in pharmaceutical regulatory affairs, with rich experience in post-marketed drug product maintenance, is preferred.
- Comprehensive knowledge of drug regulatory requirements, guidelines, and registration processes.
- Strong written and oral communication skills in both English and Chinese, with the ability to: Communicate effectively with diverse audiences and personnel.
- Negotiate and collaborate with people from various disciplines, organizations, and cultures.
Other skills:
a. Strong attention to detail and ability to manage complex information.
b. Create and manage project plans and timelines.
c. Think analytically and organize complex data effectively.
d. Proficient computer skills and experience with regulatory databases.
e. Strong learning ability and ownership of responsibilities.
Accountability/Scope:
- Execute and manage regulatory activities for drug products, ensuring deadlines are met.
- Function independently on regulatory issues, with a focus on post-marketing maintenance and compliance.
- Effectively communicate, prepare, and negotiate internally and externally with regulatory agencies.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
AN Abbott Nutrition
LOCATION:
China > Beijing : Canway Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable