长沙招聘

Primary Job Function

As a manager, the function of an Associate Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert and resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual may ensure that data are identified, obtained and effectively presented for the registration of products worldwide.



Core Job Responsibilities

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:

Strategic Planning:
- Identify need for new regulatory policies, processes and SOPs and approve them
- Evaluate regulatory risks of corporate policies
- Provide strategic guidance for product development and planning throughout the product lifecycle
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions
- Develop global regulatory strategies and update based upon regulatory changes
- Conduct regulatory due diligence for potential and new acquisitions and advise management
- Utilize technical regulatory skills to propose strategies on complex issues
- Monitor emerging issues and identify solutions
- Monitor trade association positions for impact on company products
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
- Recruit, develop and manage regulatory professionals

Premarket:
- Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing changes
- Monitor impact of changing regulations on submission strategies and update internal stakeholders
- Communicate application progress to internal stakeholders
- Monitor and submit applicable reports and responses to regulatory authorities
- Negotiate with regulatory authorities during the development and review process to ensure submission approval
- Provide strategic input and technical guidance on regulatory requirements to development teams
- Manage preapproval compliance activities
- Formulate company procedures to respond to regulatory authority queries

Postmarket:
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information
- Ensure compliance with product postmarketing approval requirements
- Review and approve advertising and promotional items to ensure regulatory compliance
- Ensure external communications meet regulations
- Review and approve labeling to ensure compliance
- Review and approve required reports, supplemental submissions and other postmarketing commitments
- Review change controls for level of change and consequent regulatory notification
- Develop, implement and manage SOPs and systems to track and manage product associated events
- Lead crisis management program development and implementation
- Identify and present option for risk mitigation to decision makers
- Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
- Report adverse events to regulatory agencies and internal stakeholders
- Represent regulatory affairs in product recall and recall communication process
Job specific responsibilities may include (choose applicable areas and expand as appropriate);
- Medical writing
- Advertising and promotion
- Labeling
- Controlled substances (e.g. DEA)
- Restricted substances (e.g. REACH)
- Compendial / standards
- Import / export
- Country specific regulatory support.


Supervisory / Management Responsibilities

Individual manages group or small department (1 - 3 people) providing direction and guidance to exempt and non-exempt personnel who exercise some latitude and independence in their assignments. Individual evaluates performance of and assists in career development planning for subordinates.



Position Accountability / Scope

Scope is division-wide regulatory direction for product development and support to develop most rapid successful strategy for approval to market products to meet business objectives; administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions. Must assure that all deadlines are met and provide effective leadership without direct authority. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as an industry expert and resource in regulatory affairs.
Influence/Leadership:
- Develops, communicates, and builds consensus for operating goals that are in alignment with the division.
- Provides leadership by communicating and providing guidance towards achieving department objectives.
- Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units.
- May lead a project team or initiative within department or cross-functions/divisions.
- Provides technical leadership to business units.
- Acts as a mentor to less-experienced staff.
- Exercises judgment independently.
Planning/Organization:
- Creates immediate to long-range plans to carry out objectives established by top management.
- Develops and calculates a budget for a department or group to meet organizational goals.
- Forecasts future departmental needs including human and material resources and capital expenditures.
- Recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.
Decision Making/Impact:
- Assignments are expressed in the form of objectives
- Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
- Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.



Minimum Education

Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)



Minimum Experience / Training Required:

5-7 years experience in a regulated industry (e.g., medical products, nutritionals). 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Note: Higher education may compensate for years of experience.

Background / Skills / Knowledge
Regulatory Knowledge of (as applicable):
- Regulatory history, guidelines, policies, standards, practices, requirements and precedents
- Regulatory agency structure, processes and key personnel
- Principles and requirements of applicable product laws
- Submission/registration types and requirements
- GxPs (GCPs, GLPs, GMPs)
- Principles and requirements of promotion, advertising and labeling
- International treaties and regional, national, local and territorial trade requirements, agreements and considerations
- Domestic and international regulatory guidelines, policies and regulations
- Ethical guidelines of the regulatory profession, clinical research and regulatory process
- Lead functional groups in the development of relevant data to complete a regulatory submission



Technical/Business Knowledge of:
- Ability to monitor costs of projects and of human and material resources within a department or unit
- Ability to monitor company-wide indicators such as market share and profitability
- Ability to monitor external environment in area of technical or professional responsibility
- Understanding and knowledge of reimbursement
Communication Skills or Ability to:
- Communicate effectively verbally and in writing
- Communicate with diverse audiences and personnel
- Write and edit technical documents
- Work with cross-functional teams
- Work with people from various disciplines and cultures
- Write and edit technical documents
- Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies
- Negotiate internally and externally with regulatory agencies and participate in political lobbying
- Plan and conduct meetings
- Demonstrated effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks
Cognitive Skills or Ability to:
- Strong attention to detail
- Manage projects
- Create project plans and timelines
- Must be able to juggle multiple and competing priorities
- Think analytically with good problem solving skills
- Organize and track complex information
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results

服务于全球医疗保健需求
我们是一家全球性的多元化医疗保健公司，致力于探索维持健康的新药品、新技术和新方法。我们的产品跨越整个医疗护理领域，从营养品和诊断产品到医疗器械和医药治疗方案。我们全线产品系列贯穿各个年龄段，满足从婴幼儿到老年人的重要健康需求。
公司在全球范围内拥有销售、制造、研发以及分销等网点，我们时刻为客户和患者着想，因此我们会随时出现在他们最需要的地方。我们的全球影响力和客户服务能力获得了广泛认可。

科学传递关爱
在我们120多年的发展历程中，雅培人一直为着一个永恒的目标而不懈地努力：推动医疗科学进步，帮助人们更健康地生活。这也是我们公司优良传统的一部分并且将继续推动我们不断向前。今天，雅培全球70,000名雅培员工共同激情投入"科学传递关爱"的行动。
这是雅培的承诺，我们相信生命拥有无限潜能，我们愿意为这份崇高的事业贡献力量。

良好的工作环境
在雅培，我们提供优良的工作环境，并被公认为优秀雇主，对此我们倍感自豪。我们以承诺提供优越的工作场所而获得了众多本地，全国及国际性的荣誉。雅培员工知道他们所得到的都是最好的—从获奖医疗保健福利到各种便利和福利服务及长期退休福利。

致力于全球领先的健康事业
我们把对生活的改善延伸到人道主义事业。作为一个生产创新型医疗保健产品的领导者，雅培认为这是我们特殊和使命来帮助人们—无论他们处于贫穷或是灾难。我们都将坚定不移地通过创新和多项社会活动来完成这项职责。

雅培成熟药品部
雅培成熟药品部（EPD）目前在中国有1200名左右员工, 拥有消化及肝病，妇科及神经科，心血管及泌尿科，疫苗产品领域的13个产品。我们诚邀充满激情，实干的精英加入我们的团队。

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