As an individual contributor, the function of a Regulatory Affairs Associate Director is to combine knowledge of scientific, regulatory l and business issues to enable products that are developed, manufactured or distributed to meet required legislation. 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 mentor 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 and Scope
Scope is divisionwide 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.
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.
Individual provides leadership without direct authority (i.e., project leader). Individual may provide direction and guidance to exempt, non-exempt and/or supervisory personnel who exercise significant latitude and independence in their assignments.
Also may mentor other department members.
Bachelors degree (or equivalent); Bachelors 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).3