Abbott Regulatory Affairs Associate in Santa Clara, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
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.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include:
· 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
· Organize materials from submissions 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
· Organize meetings with regulatory agency staff
· 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 internal audits and inspections
· Country specific regulatory support
Position Accountability and Scope
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.
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+ years experience in a regulated industry (e.g., medical products, pharma, etc). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Good computer skills with working knowledge of MS office such as Word, Excel, Outlook and Adobe Acrobat Professional.
• Working knowledge of “Styles” in Microsoft Word a plus
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
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
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 email@example.com