REGULATORY AFFAIRS SPECIALIST
Abbott Laboratories - Santa Clara, CA

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13000000UH

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 an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration 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:
  • Assist in SOP development and review
  • Provide regulatory input to product lifecycle planning
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
  • Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
  • Determine trade issues to anticipate regulatory obstacles
  • Determine and communicate submission and approval requirements
  • Participate in risk-benefit analysis for regulatory compliance
Premarket:
  • Monitor applications under regulatory review
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
Postmarket:
  • Maintain annual licenses, registrations, listings and patent information
  • Assist compliance with product postmarketing approval requirements
  • Assist in the review of advertising and promotional items
  • Assess external communications relative to regulations
  • Review regulatory aspects of contracts
  • Assist with label development and review for compliance before release
  • Submit and review change controls to determine the level of change and consequent submission requirements
  • Contribute to the development and functioning of the crisis/ issue management program
  • Ensure product safety issues and product-associated events are reported to regulatory agencies
  • 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
Position Accountability / Scope

Indicate the reporting relationships, products, budgets, throughput, level and purpose of contacts (internal and external), or other scope measures that are key to this position. Individuals execute and manage technical and scientific regulatory activities, understand regulations and guidance. Individual works under minimal supervision and independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives. Participates in conflict resolution at the team level.

Influence/Leadership:
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
  • May lead a departmental project team.
  • Participates in determining goals and objectives for projects.
  • Influences middle management on technical or business solutions.
  • May interact with vendors.
Planning/Organization:
  • Plans and organizes non-routine tasks w/approval.
  • Initiates or maintains work schedule.
  • Establishes priorities of work assignments.
Decision Making/Impact:
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
Qualifications

Minimum Education

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.

Minimum Experience / Training Required:
2-3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is 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.

Background / Skills / Knowledge

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
Cognitive Skills or Ability to:
  • Strong attention to detail
  • Manage projects
  • Create project plans and timelines
  • Think analytically
  • Organize and track complex information
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Has a sound knowledge of a variety of alternatives and their impact on the business
  • Apply business and regulatory ethical standards
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

:

Day

Travel

:

Yes, 10 % of the Time

Abbott Laboratories - 20 months ago - save job - block
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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....