What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at Abbott?
The Opportunity
This position works out of the office of our Lake Forest, IL location in the Infectious Diseases Business Unit of Abbott Diagnostics. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.
What You’ll Work On
As an individual contributor, the function of a Senior 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 play
a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining
these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may
prepare and submit documentation needed for registration worldwide or may oversee such preparation.
In addition, If hired, you will also perform these essential job duties :
- Strategic Planning : Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue
to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
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.
prepare, review and submit regulatory submission to authorities.
submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical and manufacturing changes for
regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process
to ensure submission approval.
post marketing approval requirements.
relative to regulations. Review regulatory aspects of contracts. Assist with label development and review for compliance
before release.
input of cumulative product changes to current product submissions.
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).
REACH), Compendial / standards, Import / export, Country specific regulatory support.
Communicate effectively verbally and in writing.
Communicate with diverse audiences and personnel.
Required Qualifications
Major / Field of Study Or Education Level
Bachelors Degree (± 16 years) Related field. an equivalent combination of education and work experience
Preferred Qualifications :
Masters Degree (± 18 years) In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.
Experience / Background
Minimum 3 years' experience in similar area.
3-or more years of experience in a regulated industry (e.g., medical products, nutritionals). 2 or more years of experience in regulatory preferred but may consider quality assurance, research and development / support, scientific affairs, operations, or related area. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Knowledge of : Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
GxPs (GCPs, GLPs, GMPs).
Preferred Qualifications :
Principles and requirements of promotion, advertising and labeling.
Write and edit technical documents
Work with cross-functional teams.
Work with people from various disciplines and cultures.
Negotiate internally and externally with regulatory agencies.
Pay strong attention to detail.
Manage projects.
