Regulatory Affairs Director
Regulatory Affairs Director
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Job Description
JOB DESCRIPTION:
Works in a strategic role and demonstrates organizational influence
1. Product registrations /Submissions
-Develops and directs regulatory plans for product and/or geographic groups assigned and ensures they are in-line with business needs
-Reviews regulatory data packages for major submissions prior to filing and during the approval process
2. Relationships & Cross Functional team work
-Maintains effective working relationships with Divisional RA
-Negotiates with and influences Manufacturing QA Commercial Development management to support EPD regulatory needs
-Trains develops and manages an effective team
3. Compliance across Life-Cycle
- Ensures that all new products are registered and the existing marketed product registrations are maintained
globally in line with business needs and regulatory standards
-Identifies areas of regulatory or compliance risk and establishes programs to reduce risk
-Supports team to assure products remain in compliance
4. Strategy
Ensures that agreed regulatory strategies are efficiently implemented and that strategies are maintained inline
with changing regulatory needs and business needs
-Develops and implements internal and external strategies to proactively influence legislation/guidelines with
impact on Abbott business
-Sets policy and assures standard interpretation of regulations
-Provides regulatory leadership and expertise to licensing colleagues
-Conducts succession planning
-Provides strategy and direction to teams involved in agency activities
5. Process Improvement
-Champion business and efficiency improvements
- Establishes vision and drives change management initiatives
6.Health Agency Interaction
- Attends at Agency meetings such as key policy meeting major filing or strategy meetings
- Directs and/or provides input into interaction/communication with Agency reviewers and key Agency senior policy staff.
7. Licensing Reviews
-Actively supports in-licensing opportunities.
8.People Management
- Manage and empower the RA team by open communication regular performance review prompt and appropriate feedback and coaching employee training needs analysis and practice
- Provide the necessary leadership to ensure appropriate direction employees motivation and efficient accomplishment of key performance results
- Create and maintain a workplace culture which attracts grows and retains highly qualified employees by proper succession planning and talent development policies and tools
- Demonstrate promote and live the COMPANY Values in all interactions
Core Job Responsibilities:
Provide strategic input into the development of assigned projects handling complex issues and providing leadership where appropriate to assigned team.
Responsible for managing strategic partnership with Manufacturing QA Commercial Development and Divisional RA
Represent RA at China management meetings
Support strategic regulatory plans and present to management for agreement.
Ensure development and execution of China regulatory strategies for all projects consistent with commercial strategies.
Resolve complex issues with cross functional senior counterparts as required ensuring compliance with regulatory and scientific standards and identification of regulatory risk.
Monitor actual vs. planned activities and timelines.
Identify and recommend improvements to correct or accelerate project progression.
Manage regulatory resources within assigned area to ensure regulatory approvals.
Prepare and present written and oral reports and other presentations to internal and external audiences
Adjusts presentation style and content to suit the audience across.
Direct and manage the preparation and review of technical strategic regulatory documentation for agency submission.
Sets quality and accuracy standards for staff team and ensure application
Position Accountability/Scope:
Effective Interface within RA (Divisional Affiliate) and broader Abbott Organization
Works with internal and external levels of the organization usually at higher levels of the organization
Project or Geographic or TA Accountability
Manage Projects (Development In-Licensing Life Cycle) within China
Scope of Accountability
(budget resources planning)
Oversees activities and prioritizes to assure costs are maintained within budget
Accountable for input into strategic budgets LBE and update planning with completion within scheduled completion date and within budget constraints.
Provides input to secure and justify funding.
Allocates resource across team to ensure effective use of available resources.
Resolution Prediction of regulatory issues
Anticipate long-term future problems resolve current issues.
Learns and adjusts based on prior results and prior project leadership experience.
Awareness and application of Regulatory Intelligence
Develop and implement internal and external strategies to proactively:
Take lead to respond to legislation/guidance with impact on Abbott business address changes in the regulatory
environment impacting key projects
Ability to take lead to help direct project teams to resolve regulatory issues.
Impact on regulatory policy and regulations
Assures review and application of policy within assigned area.
Assesses regulatory issues for potential implications to projects outside of relevant area and ensures communication and resolution including liaison with other functional areas as required.
Ensures standard communication across all projects and external customers and stakeholders
Leads teams to respond to health agency draft policy or scientific guidelines.
Minimum Education:
Bachelors Degree in pharmacy biology chemistry pharmacology or related subject.
A relevant Masters Degree is preferred
Minimum Experience/Training Required:
10 years in Regulatory R&D or related area minimum of 5-year experience preferred in pharmaceutical regulatory affairs ideally includes at least 3-5 years team management experience
Ability to operate across global cultures. Fluent English both oral and written.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
China > Beijing : Canway Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Director
Employment Type
Full-Time
