Job Title: Regulatory Specialist
Location: Rosemont, IL - Remote
Duration: Long Term Contract
Key Responsibilities:
· Provide strategic input and technical guidance on regulatory requirements to R&D project teams.
· Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company.
· Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high-quality submissions.
· Monitor product-related activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices.
· Review all supporting documentation required in regulatory applications for accuracy and completeness and determine the applicability of supporting documentation for inclusion in regulatory submission.
· Keep abreast of additions, changes, and emerging trends to regulations and guidelines and evaluate relevance to company and products.
· Provide the regulatory perspective on Due Diligence activities in support of potential new business opportunities. Review data/information as needed.
· Be familiar with Global regulatory aspects of all the global products; contribute to discussions and regulatory strategies as needed.
· Establish expertise on guidelines and regulatory requirements for combination products.
· Ensure the maintenance of FDA Controlled Correspondences log in an easily searchable format to enable quick reference to resolved issues.
· Ensure the maintenance of FDA Information Requests log for A/NDAs in an easily searchable format to provide insight into FDA review trends.
· Review and oversee the development and/or revision of Standard Operation Procedures as they relate to cGMP quality and regulatory compliance.
Required Education and Experience:
· BS/BA required in a scientific discipline.
· Minimum of 12 years of experience in the pharmaceutical/biotech industry within the Regulatory Affairs/R&D functions.
· Deep and broad knowledge of regulatory affairs.
· Direct, hands-on experience with pharmaceutical regulatory submissions and product approvals.
· Experience with post-approval life cycle management of marketed products.
· Proven track record of effective collaboration with regulatory agencies, including the FDA
· Solid knowledge of cGMP regulations and current industry trends related to pharmaceutical and biological products.
· Thorough understanding of the applicable sections of the US Code of Federal Regulations, FDA/ICH guidelines and cGMP''s, as they pertain to pharmaceuticals.
· Advanced degree in a scientific discipline preferred
· Must be able to serve as the company expert on regulatory affairs.
· Strong entrepreneurial abilities, sense of urgency, and team player.
· Well-developed organizational, interpersonal, and project management skills.
· Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions.
· Experience with combination products.
· Excellent written and verbal communication required.
· Must be willing to travel.