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Abbott Director, Regulatory Affairs- Latin America in Pleasanton, California

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.

POSITION OBJECTIVE:

The function of the Director, Regulatory Affairs for Latin America is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation in all Latin American countries. Additionally, the individual will develop and supervise regulatory professionals. The individual has division level influence and is generally considered a key opinion leader and an expert resource both within Abbott and externally on all Latin America Regulatory Affairs issues. The individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual will plan, budget, direct, coordinate and control the regulatory affairs activities for all Latin America countries.

CORE JOB RESPONSIBILITIES:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Core job responsibilities for this function may include:

Strategic Planning:

  • Identify need for new regulatory policies, processes and SOPs and approve them

  • Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture

  • Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle

  • Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions

  • Develop Latin America regulatory strategies and update based upon regulatory changes

  • Conduct regulatory due diligence for potential and new acquisitions and advise management

  • Sets quality and accuracy standards

  • Anticipate emerging issues and develop solutions to them

  • Develop solutions to address issues with other members of management and stakeholders (i.e., Regional DVPs and GMs)

  • Create and develop product positioning strategies based upon regulatory requirements

  • Integrate regulatory considerations into the corporation’s global product entry and exit strategy

  • Recruit, develop, and mentor regulatory professionals

  • Provide guidance for resource and development planning

  • Participate in applicable trade association/industry working groups to influence policy/rulemaking in alignment with business strategies

Premarket:

  • Communicate application progress to internal stakeholders

  • 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

  • Ensure preapproval compliance activities are completed

  • Formulate company responses to respond to regulatory authority queries

Postmarket:

  • Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests

  • Ensure a system is in place to manage access to information requests

  • Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance

  • Ensure crisis management program implemented and functioning

  • Identify and present option for risk mitigation to decision makers

  • Represent regulatory affairs in product recall and recall communication process

  • Manage processes involved with maintaining annual licenses, registrations, listings, etc.

  • Ensure compliance with product post-marketing approval requirements

  • Review and approve advertising and promotional items to ensure regulatory compliance

  • Review and approve publicly disseminated information to minimize regulatory exposure; review product claims, and preserve confidentiality of applicable product information

POSITION ACCOUNTABILITY / SCOPE:

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; attract and develop superior regulatory professionals and regulatory competencies. Must assure that all deadlines are met and provide effective leadership without direct authority. Work is performed without appreciable direction and exercises significant latitude in determining technical objectives of assignments; assignments are often self-initiated;

determines and pursue courses of action necessary to obtain desired results. Completed work is checked through consultation and agreement with others rather than by formal review of superior. Individual is

recognized as a key opinion leader and resource in regulatory affairs.

Influence/Leadership:

  • Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation.

  • Provides leadership by communicating and providing guidance towards achieving department, division and/or corporate 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 internal and external to the department/division.

  • · Exercises judgment independently.

  • · Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit and company objectives.

  • · May participate / lead external industry working groups to influence advocacy in alignment with business strategies.

Planning/Organization:

  • Creates mid- to long-range plans to carry out objectives established by top management.

  • Develops and calculates a budget for one or more departments to meet organizational goals.

  • Forecasts future departmental or group needs including human and material resources and capital expenditures.

  • Determines and establishes organizational structure and supervisory relationships subject to top management approval.

Decision Making/Impact:

  • Assignments are expressed in the form of objectives

  • Work is performed without appreciable direction.

  • 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 delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

EDUCATION/Certifications:

Bachelor's degree (or equivalent); 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.

10+ years’ experience in a regulated industry (e.g., medical products, nutritionals). 10+ years of experience in regulatory preferred but will consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.

Six Sigma Certification preferred

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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