ABBOTT LABORATORIES Regulatory Affairs Associate Salary in the United States

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.