W-2 Contract Role
Duration - 1 Year
Location - Cary, IL 60013
Pay - Up to $64.45/hour
This is a highly specialized individual contributor role that requires deep expertise from a professional / technical thought leader in their respective field or discipline. This position typically requires extensive experience in a specialized field and an advanced college degree or equivalent. The role requires expertise within a discipline in a specialized field. The job provides technical guidance and direction for his/ her area of specialization. The job requires good analytical skills as well as evaluative judgement based on the analysis of factual and qualitative information in complicated or novel situations. The complexity implied at this level of problem solving relates to the ability to filter, prioritize, analyze and validate potentially complex and dynamic material. This job typically requires a degree or equivalent and a minimum of 6 or more years' experience.
Key Areas of Responsibility:
* Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
* Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature
* Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
* Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
* Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
* Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
* Evaluates proposed products for regulatory classification and jurisdiction
* Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
* Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
* Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
* Negotiates with regulatory authorities throughout the product lifecycle
* Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
* Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
* Assists other departments in the development of SOPs to ensure regulatory compliance
* Provides regulatory input and technical guidance on global regulatory requirements to product development and sustaining teams
* Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
* Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
* Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
* Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
* Identifies, monitors, and submits applicable reports or notifications to regulatory authorities
* Provides regulatory information and guidance for proposed product claims/labeling
* Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
* Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
* Monitors the progress of the regulatory authority review process through appropriate communications with the agency
* Communicates and interacts with regulatory authorities before and
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.