Regulatory Affairs Director

Abbott

  • Beijing
  • Permanent
  • Full-time
  • 1 month ago
JOB DESCRIPTION:Works in a strategic role and demonstrates organizational influence1. 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 process2. 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 team3. Compliance across Life-Cycle- Ensures that all new products are registered, and the existing marketed product registrations are maintainedglobally 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 compliance4. StrategyEnsures that agreed regulatory strategies are efficiently implemented, and that strategies are maintained inlinewith changing regulatory needs and business needs-Develops and implements internal and external strategies to proactively influence legislation/guidelines withimpact 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 activities5. Process Improvement-Champion business and efficiency improvements- Establishes vision and drives change management initiatives6. 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 interactionsCore 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 RARepresent RA at China management meetingsSupport 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 audiencesAdjusts 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 applicationAdditional Job DescriptionPosition Accountability/Scope:Effective Interface within RA (Divisional, Affiliate) and broader Abbott OrganizationWorks with internal and external levels of the organization, usually at higher levels of the organizationProject or Geographic or TA AccountabilityManage Projects (Development, In-Licensing, Life Cycle) within ChinaScope of Accountability(budget, resources, planning)Oversees activities and prioritizes to assure costs are maintained within budgetAccountable 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 issuesAnticipate long-term future problems, resolve current issues.Learns and adjusts based on prior results and prior project leadership experience.Awareness and application of Regulatory IntelligenceDevelop and implement internal and external strategies to proactively:Take lead to respond to legislation/guidance with impact on Abbott business address changes in the regulatoryenvironment impacting key projectsAbility to take lead to help direct project teams to resolve regulatory issues.Impact on regulatory policy and regulationsAssures 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 stakeholdersLeads teams to respond to health agency draft policy or scientific guidelines.Minimum Education:Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject.A relevant Master's Degree is preferredMinimum 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 experienceAbility 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 OperationsDIVISION: EPD Established PharmaLOCATION: China
Beijing : Canway BuildingADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Not specifiedMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott