Regulatory Specialist

Description: 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.