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Global Regulatory Lead (GRL)

  • GE Healthcare
  • Experienced
  • Posted 11/14/2017 5:50:44 PM
  • 2921789
  • Job Function: Quality
  • Business Segment: Healthcare Life Sciences
Location(s): Canada, China, Denmark, Germany, Hong Kong, Japan, Mexico, Netherlands, Norway, Russian Federation, United Arab Emirates, United Kingdom, United States; Alabama, Alaska, Alberta, American Samoa, AnHui, Arizona, Arkansas, BeiJing, British Columbia, California, ChongQing, Colorado, Connecticut, Delaware, District of Columbia, Florida, FuJian, GanSu, Georgia, Guam, GuangDong, GuangXi, GuiZhou, HaiNan, Hawaii, HeBei, HeiLongJiang, HeNan, Hong Kong, HuBei, HuNan, Idaho, Illinois, Indiana, Iowa, JiangSu, JiangXi, JiLin, Kansas, Kentucky, LiaoNing, Louisiana, Macao, Maine, Manitoba, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nei Mongol, Nevada, New Brunswick, New Hampshire, New Jersey, New Mexico, New York, Newfoundland and Labrador, Ningxia, North Carolina, North Dakota, Northern Mariana Islands, Northwest Territories, Nova Scotia, Nunavut, Ohio, Oklahoma, Ontario, Oregon, Pennsylvania, Prince Edward Island, Puerto Rico, Qinghai, Quebec, Rhode Island, Saskatchewan, ShaanXi, ShanDong, ShangHai, ShanXi, SiChuan, South Carolina, South Dakota, Taiwan, Tennessee, Texas, TianJin, United States Minor Outlying Islands, Utah, Vermont, Virgin Islands, U.S., Virginia, Washington, West Virginia, Wisconsin, Wyoming, XinJiang, Xizang, Yukon, YunNan, ZheJiang; UK, Global,


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Role Summary:
Single point of accountability for Global Regulatory Strategy Leadership. Own and drive the regulatory strategy setting process for New Product Introductions, Major Line Extensions and New Market Entry submissions. The GRL co-ordinates the Global Regulatory Team and is ‘the face’ of the Global Regulatory function on cross functional Global Project teams.

Essential Responsibilities:

• To deliver high quality implementable regulatory strategies and plans that take account of current and emerging global regulatory requirements
• Ensures delivery of assigned major new product filings and lifecycle registrations and that compliance commitments are met
• Regulatory Leadership for a portfolio of projects at different stages across the life cycle
• Leads Global Regulatory Teams, ensuring effective co-ordination and appropriate input from regional RA colleagues and other regulatory groups bringing their expertise to bear and ensuring that an effective Global Strategy is developed
• Engenders close and effective working with Regional Regulatory, RISM colleagues and external contractor resources to deliver high quality regulatory strategies and approvable submissions
• Builds effective business focused relationships with a wide range of functions including colleagues in R&D, Commercial, Project Management, Supply Chain, Pharmacovigilance and Quality Assurance functions to ensure that Regulatory Affairs is a full partner in supporting GEHC strategic aims
• Provide consistent expert advice to the organization, determining feasible regulatory strategies and identify potential options, to assist in delivering optimal business value or mitigate compliance issues
• Builds proactive and effective relationships with major regulatory agencies
• Provides full support to GHRS in providing workload estimates to enable effective capacity planning and prioritisation
• Attends life cycle and project leadership meetings and other major decision making bodies as required
• Participates as a full and active member of the Global Regulatory Strategy (GRS) team



Qualifications/Requirements:

Required Qualifications and Experience:

• Extensive experience of global regulatory affairs from the pharmaceutical and/or healthcare industry
• Significant experience of regulatory project management and regulatory agency interactions
• Experience of managing regulatory projects in global regulatory organizations
• Experience of working globally and across different cultures
• Effective communication and negotiation skills, both written and verbal

Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website

http://www.ukba.homeoffice.gov.uk/visas-immigration/working



Desired Characteristics:

Personal Attributes:

• Persuasive and Influential
• Effective communicator
• Strong team leadership skills 
• Ability to harness team expertise and engender team work
• Assertive and willing to make decisions
• Ability to make sound business judgments
• Ability to juggle multiple competing tasks
• Ability to set and make clear priorities
• Tenacious with a “can do” attitude
• Completer finisher and Implementer



Locations: Canada, China, Denmark, Germany, Hong Kong, Japan, Mexico, Netherlands, Norway, Russian Federation, United Arab Emirates, United Kingdom, United States; Alabama, Alaska, Alberta, American Samoa, AnHui, Arizona, Arkansas, BeiJing, British Columbia, California, ChongQing, Colorado, Connecticut, Delaware, District of Columbia, Florida, FuJian, GanSu, Georgia, Guam, GuangDong, GuangXi, GuiZhou, HaiNan, Hawaii, HeBei, HeiLongJiang, HeNan, Hong Kong, HuBei, HuNan, Idaho, Illinois, Indiana, Iowa, JiangSu, JiangXi, JiLin, Kansas, Kentucky, LiaoNing, Louisiana, Macao, Maine, Manitoba, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nei Mongol, Nevada, New Brunswick, New Hampshire, New Jersey, New Mexico, New York, Newfoundland and Labrador, Ningxia, North Carolina, North Dakota, Northern Mariana Islands, Northwest Territories, Nova Scotia, Nunavut, Ohio, Oklahoma, Ontario, Oregon, Pennsylvania, Prince Edward Island, Puerto Rico, Qinghai, Quebec, Rhode Island, Saskatchewan, ShaanXi, ShanDong, ShangHai, ShanXi, SiChuan, South Carolina, South Dakota, Taiwan, Tennessee, Texas, TianJin, United States Minor Outlying Islands, Utah, Vermont, Virgin Islands, U.S., Virginia, Washington, West Virginia, Wisconsin, Wyoming, XinJiang, Xizang, Yukon, YunNan, ZheJiang; UK, Global,

GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.


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