- Provide regulatory input to product lifecycle planning. Assist in SOP development and review.
- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
- Determine trade issues to anticipate regulatory obstacles. Participate in risk benefit analysis for regulatory compliance.
- Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
- Assist in preparation and review of regulatory submission to authorities.
- Maintain annual licenses, registrations, listings and patent information.
- Assist compliance with product postmarketing approval requirements. Assist in the review of advertising and promotional items.
- Assess external communications relative to regulations. Review regulatory aspects of contracts.
- Assist with label development and review for compliance before release.
- Submit and review change controls to determine the level of change and consequent submission requirements.
- Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications.
- Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments. May lead a departmental project team.
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Influences middle management on technical or business solutions.
- May interact with vendors.
- Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.
- Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology) math, engineering, or medical fields is preferred
- 2-3 years of experience in a regulated industry (e.g. medical products, nutritionals)
- Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
- Experience with 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; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process.
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Regulatory Affairs Specialist - Lake Forest, United States - GForce Life Sciences
Description
Regulatory Affairs Specialist Onsite in Lake Forest, IL
Must be able to work W2
Summary
Our client, a Fortune-500 Medical Device Company, has requested that we find them a regulatory affairs specialist to provide support and ensure efficient and compliant business processes and environment. This candidate will assist in the registration of products by preparing and submitting necessary documentation for registration worldwide.
Day-to-Day Duties
Mandatory Requirements
Nice to have
Term & Start
12-month contract with possibility to extend
FT, M-F 40h/week
Pay Rate: $25-30/hr ($50-60K annually)
Onsite in: Lake Forest, IL
