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.
As an individual contributor, the function of a Reglatory Affairs Project Manager is to combine the knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. 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 epxertise 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.
Responsible for compliance with applicable Corporate and Divisional policies and procedures.
Core job responsibilities may include:
Job specific responsibilities:
- Develop new regulatory policies, processes and SOPs and train key personnel on them
- Utilize technical regulatory skills to propose strategies on complex issues
- Determine submission and approval requirements
- Identify emerging issues
- 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 regularoty and related items
- Act as a primary Submission Operations liason with IT and other functions to plan, test, and execute publishing-related software upgrades. Work with Resource Managers to identify internal resources required to support process definition, quality systems updates, and software testing activities to meet project timelines. Assist in the coordination of training, as needed.
- Develop and/or facilitate development of recommendations for processes and standards relating to publishing deliverables. Work with Submission Operations leadership team to implement updated processes and/or standards.
- Identify the impact of changes in regulations for global submissions. Recommend changes to software and business processes to support changing regulations.
- Participate on cross-functional project teams, as a Submission Operations representative to ensure that Submission Operations' requirements are adequately addressed.
- In support of production related publishing related activities, troubleshoot software issues, liase with IT, identify workarounds for software bugs, ensure all issues and workarounds are documented, communication and staff is trained.
Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regualtory agencies. Properly interpret and apply regulatory requirements. 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 reognized as a discipline expert and resource in regulatory affairs.
- Develops, communicates, and builds consensus for operating goals that are in alignement with the division.
- Provides leadership by communicating and providing guidance towards achieving department objectives.
- Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
- May lead a cross functional or cross divisional project team.
- Provides technical leadership to business units.
- Acts as a mentor to less experienced staff.
- Exercises judgement independently.
- Creates immediate to long range plans to carry out objectives established by top management.
- Forecasts project related needs including human and material resources and capital expenditures.
- 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.
Bachelor's degree (or equivalent); Bachelor's degree in science (chemistry, biology, 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:
4-5 years in a regulated industry (e.g. medical products, nutrionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development, scientific affairs, operations, or related area.
Note: Higher education may compensate for years of experience.
Regulatory Knowledge (as applicable):
Communication Skills or Ability to:
- Regulatory history, guidelines, policies, standards, practices, requirements, and precedents
- Regulatory agency structure, processes, and key personnel
- Principles and requirements of applicable product laws
- Submissions/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
Cognitive Skills or Ability to:
- Communicate effectively verbally and in writin
- Communicate with diverse audiences and personnel
- Write and edit technical documents
- Work with cross fuctional teams
- Work with people from various disciplines and cultures
- Write and edit technical documents
- Negitoate internally and externally with regulatory agencies
- Plan and conduct meetings
Preferred technical skills:
- 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 judgement 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
- 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 assessments or analysis
- Lead functional groups in the development of relevant data to complete a regulatory submission
Significant Work Activities and Conditions
- Expert in the use of publishing related software tools such as Documentum, eCTDXPress, ISI Toolbox, and/or Adobe Acrobat. Thourough understanding of MS Word.
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Yes, 20 % of the Time