MANAGER, REGULATORY AFFAIRS
Abbott Laboratories - Santa Clara, CA

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120000006L

Description

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.

PRIMARY JOB FUNCTION:
As a manager, the function of a Manager 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/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may analyze broad scope implications of changing regulations and guidance. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.

CORE JOB RESPONSIBILITIES:
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 multicountry 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 manage 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
Postmarket:
  • Oversee processes involved with maintaining annual licenses, registrations, listings and patent information
  • Ensure compliance with product postmarketing 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
  • Analyze product-associated problems and develop proposals for solutions
  • 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
COMMENTS:
Individual manages group or small department providing direction and guidance to exempt and non-exempt personnel. Individual evaluates performance of and assists in career development planning for subordinates.

POSITION ACCOUNTABILITY / SCOPE:
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.

Influence/Leadership:
  • 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.
Planning/Organization:
  • 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 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.
Decision Making/Impact:
  • 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.
Qualifications

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. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

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-California-Santa Clara

Organization

:

AVD-Vascular

Schedule

:

Full-time

Shift

:

Morning

Travel

:

Yes, 20 % of the Time

About this company
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Filling baby bottles and treating disease... these are the habits of Abbott. Abbott Laboratories is a top health care products manufacturer....