At Abbott, we’re committed to helping you live your best possible life through the power of health. For more than 125 years, we’ve brought new products and technologies to the world — in nutrition, diagnostics, medical devices and branded generic pharmaceuticals — that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
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 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.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
- 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.
- 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.
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
- Ensure compliance with product post marketing 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 post marketing 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.
- Accountability / Scope / Budget
- 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.
- 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.
- 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.
- 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.
- Individual manages group or small department 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.
Minimum Education & Experience
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.) 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 5-7 years’ experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience. 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 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 and global regulatory agencies Negotiate internally and externally with regulatory agencies and participate in political lobbying Plan and conduct meetings Demonstrate effective use of negotiation skills to resolve regulatory issues in cross functional teams to ensure completion of project tasks 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 to complete a regulatory submission Monitor costs of projects and of human and material resources within a department or unit Monitor companywide indicators such as market share and profitability Monitor external environment in area of technical or professional responsibility Understand reimbursement
United States > Roseville : 2825 Fairview Avenue North
Yes, 25 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
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