Manager of Regulatory Affairs Operations
AbbVie - Lake County, IL

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Manager of Regulatory Affairs Operations - 13000000WN Description
      AbbVie (NYSE: ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.

      Primary Job Function:

      The function of a Regulatory Affairs Registration Compliance Manager is to combine the knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet global legislation requirements. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.

      Core Responsibilities:

      Responsible for compliance with applicable Corporate and Departmental policies and procedures.

      Core job responsibilities may include:

      Strategic Planning:
      ·
      Develop new regulatory policies, processes and SOPs and approve them
      ·
      Evaluate regulatory risks of departmental policies, processes, procedures
      ·
      Utilize technical regulatory skills to propose strategies on complex issues
      ·
      Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory
      ·
      Monitor trade association positions on pending legislation for impact on company products
      ·
      Recruit, develop and manage/mentor regulatory professionals and contractors
      Job Specific responsibilities:
      ·
      Manages interface with other areas of Regulatory, Operations and Pharmacovigilance for key data issues
      ·
      Defines, implements, assesses and reports monthly metrics to Senior Management
      ·
      Partners with IMO to ensure business needs are met
      ·
      Maintains, monitors and provides input on the regulatory environment and policies to understand new regulations, assess implications to business, develop and execute strategies to the regulations
      ·
      Participates on cross-functional project teams, as a Registration Management representative to ensure that Registration Managements’ requirements are adequately addressed or provide strategic input for the maintenance of registration of products
      ·
      Conducts risk assessments and develop contingency plans to accommodate unforeseen events
      ·
      Monitor and participate in industry and agency initiatives around area of responsibility
      ·
      Provide direction to departmental staff. Provide direction and oversight on all projects within area of responsibility
      ·
      Develop, execute and implement business processes for Registration Compliance
      ·
      Management of 2-7 direct reports
      Background/Skills/Knowledge
      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
      · Prepare and present written and oral reports and other presentations to internal and external audiences, including senior management
      · Plan and conduct meetings
      · Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks
      Cognitive Skills or Ability to:
      · Pay strong attention to detail
      · Manage projects
      · Create project plans and timelines
      · Juggle multiple and competing priorities
      · Think analytically with good problem solving skills
      · Organize and track complex information
      · Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
      · Has broad knowledge of various technical alternatives and their potential impact on the business
      · Exercise good and ethical judgment within policy and regulations
      · Use in-depth knowledge of business functions and cross group dependencies/ relationships
      · Define regulatory strategy
      · Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
      · Perform risk assessment or analysis
      · Develop and/or identify new work processes and the improved utilization of human and material resources within the assigned or related functions or groups
      · Investigate and solve problems that impact work processes and personnel within or across units or departments
      · Develop and communicate a vision for the organizational unit assigned
      · Lead functional groups in the development of relevant data for tracking a regulatory submission
      Preferred technical skills:
      -Practiced in use of EV Web and in depth knowledge of EMA Regulation 726/2004 Article 57(2) with regards to eXtended EudraVigilance Medicinal Product Report Message (XEVPRM)
      -PMP certification from the Project Management Professionals
      Qualifications
      Basic Qualifications:
      4-5 years experience in a regulated industry (e.g., medical products, nutritionals). 2-5 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
      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
      · Negotiate internally and externally with regulatory agencies
      · Plan and conduct meetings
      Cognitive Skills or Ability to:
      · Pay strong attention to detail
      · Manage projects
      · Create project plans and timelines
      · Juggle multiple and competing priorities
      · Think analytically with good problem solving skills
      · Organize and track complex information
      · Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
      · Has broad knowledge of various technical alternatives and their potential impact on the business
      · Exercise good and ethical judgment within policy and regulations
      · Use in-depth knowledge of business functions and cross group dependencies/ relationships
      · Define regulatory strategy
      · Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
      · Perform risk assessment or analysis
      · Lead functional groups in the development of relevant data to complete a regulatory submission
      Education Requirements:
      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
      Significant Work Activities and Conditions Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
      Job Classification : Experienced
      Job : COMPLIANCE/REGULATORY AFFAIRS
      Primary Location : USA-Illinois-Lake County

      Organization : PPG-Pharma Grp
      Schedule : Full-time
      Shift : Day
      Travel : Yes, 20 % of the Time

      AbbVie - 18 months ago - save job - block
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