Regulatory Affairs Project Manager
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine 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 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.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Core job responsibilities for this function may include Strategic Planning
- Develop new regulatory policies, processes and SOPs and train key personnel on them
- Evaluate regulatory risks of division policies, processes, procedures
- Provide regulatory input to product lifecycle planning·
- Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
- Assist in regulatory due diligence for potential and new acquisitions
- 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 regulatory and related teams
- Recruit, develop and mentor regulatory professionals
- Premarket- Assess the acceptability of quality, preclinical and clinical documentation for submission filing
- Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
- Compile, prepare, review and submit regulatory submission to authorities
- Monitor impact of changing regulations on submission strategies and update internal stakeholders
- Monitor applications under regulatory review· Communicate application progress to internal stakeholders
- Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
- Negotiate and interact 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 and execute preapproval compliance activities
- Post market- 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
- Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events
- Actively contribute to the development and functioning of the crisis/issue management program
- 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
- Provide regulatory input for product recalls and recall communications
- Job specific responsibilities may include (choose applicable areas and expand as appropriate) Medical writing· Advertising and promotion· Labeling· Controlled substances (e.g. DEA) Restricted substances (e.g. REACH). Compendial / standards· Import / export· Country specific regulatory support
- 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 regulatory 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 recognized as a discipline 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 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 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.
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.)
- 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.
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