ABBOTT LABORATORIES Regulatory Affairs Associate Salary in the United States

How much does a Regulatory Affairs Associate make at companies like ABBOTT LABORATORIES in the United States? The average salary for Regulatory Affairs Associate at companies like ABBOTT LABORATORIES in the United States is $77,024 as of January 26, 2024, but the range typically falls between $65,050 and $88,997. Salary ranges can vary widely depending on many important factors, including education, certifications, additional skills, the number of years you have spent in your profession. With more online, real-time compensation data than any other website, Salary.com helps you determine your exact pay target.  View the Cost of Living in Major Cities2

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What does a Regulatory Affairs Associate do at companies like ABBOTT LABORATORIES?

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 Associate is to provide support for regulatory processes and procedures. The individual may execute tasks and exercise influence generally at the peer level. The individual may maintain current registrations by preparing documentation required and submitting documentation on schedule as directed.

MAIN RESPONSIBILITES

•Strategic Planning: Assist in SOP development, review and initiation; Stay abreast of regulatory procedures and changes in regulatory climate and update department; Investigate regulatory history of similar products to assess approval implications; Conduct research on submission requirements and options; Assist in monitoring and reporting project timelines; Respond to regulatory information requests; and Monitor and utilize tracking and control systems.

This individual may be responsible for review of advertising & promotion material and support marketing activities.

•Premarket: Organize materials from preclinical and clinical studies for review and assist in review process; Compile and organize materials for presubmission reports; Coordinate and assist in the preparation of submission/registration packages; Coordinate registration requests and track completion; Implement submission templates; Oversee quality control of regulatory documents and submissions; and Organize meetings with regulatory agency staff.

•Postmarket: Update and maintain global product listings, facility registrations, licenses/approvals, and annual registrations; Assist in the preparation of routine reports and regulatory agency communications; Assist in the preparation of postmarket reports and submissions; Update and maintain paper/electronic document archival systems; Prepare legal documents for import/export, registrations, tenders/bids or other purposes; Assist with review of promotional items; Coordinate internal audits and inspections; and Assist with global vigilance reporting and regulatory field actions such as recalls or corrections & removal.s

•Job specific responsibilities may include: Medical writing, Advertising and promotion, Labeling, Controlled substances (e.g. DEA), Restricted substances (e.g. REACH), Compendial / standards, Import / export; and Country specific regulatory support.

•Individuals coordinate and support technical and scientific regulatory activities, research regulations and guidance, and maintain and organize key information sources.

•Individual works under general supervision, receives limited supervision on standard issues, and detailed instructions on new assignments.

•Work is reviewed for soundness of judgment, overall adequacy and accuracy.

•Influence/Leadership: Establish and cultivate a network of internal resources to facilitate completion of tasks. Individual influence is typically exerted at the peer level.

•Planning/Organization: Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.

•Decision Making/Impact: May exercise authority within pre-established limits and approval. Failure to achieve results can normally be overcome without serious effect on the business.

QUALIFICATIONS

Bachelors Degree -In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred or an equivalent combination of education and work experience

Minimum 2 years 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.

Regulatory Knowledge of:

  • 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. Note: This knowledge may be developed through tenure in this position.
  • Communication Skills or Ability to:
  • Communicate effectively verbally and in writing.
  • Learn to write and edit technical documents.
  • Work with cross-functional teams.
  • Work with people from various disciplines and cultures.
  • Cognitive Skills or Ability to:
  • Pay strong attention to detail.
  • Handle detailed tasks and prioritize them.
  • Meet deadlines.
  • Think analytically and critically.
  • Review and analyze documentation.
  • Research and locate information on regulatory requirements and products.
  • Exercise judgment within defined procedures and practices to determine appropriate action.
  • Has general knowledge of technical alternatives and gain an understanding of their impact on the systems environment.
  • Apply business ethical standards.
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$65,050 Low Average $77,024 High $88,997

Understand the total compensation opportunity for Regulatory Affairs Associate at companies like ABBOTT LABORATORIES, base salary plus other pay elements

Average Total Cash Compensation

Includes base and annual incentives

$65,050
$88,997
$77,024
The chart shows total cash compensation for the ABBOTT LABORATORIES Regulatory Affairs Associate in the United States, which includes base, and annual incentives can vary anywhere from $65,050 to $88,997 with an average total cash compensation of $77,024. Total compensation includes the value of any benefits received in addition to your salary and some of the benefits that are most commonly provided within a total compensation package including bonuses, commissions, paid time off, and Insurance. The total cash compensation may get paid differently by industry, location, and other factors.
Job Openings for ABBOTT LABORATORIES Regulatory Affairs Associate
Cassaday & Company - McLean , VA
Ensure regulatory compliance is followed. * Process Required Minimum Distributions. * Assist staff ... affairs. * Professional, service-oriented demeanor with pleasant, business-appropriate phone ...
ZipRecruiter - 18 days ago

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