Description:
Key Responsibilities:
1. Provide strategic input and technical guidance on regulatory requirements to R&D project teams.
2. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. 3. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high quality submissions.
4. Monitor product-related activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices. 5. Review all supporting documentation required in regulatory applications for accuracy and completeness and determine the applicability of supporting documentation for inclusion in regulatory submission.
6. Keep abreast of additions, changes, and emerging trends to regulations and guidelines and evaluate relevance to company and products.
7. Provide the regulatory perspective on Due Diligence activities in support of potential new business opportunities. Review data/information as needed.
8. Be familiar with Global regulatory aspects of all the global products; contribute to discussions and regulatory strategies as needed. 9. Establish expertise on guidelines and regulatory requirements for combination products.
10. Ensure the maintenance of FDA Controlled Correspondences log in an easily searchable format to enable quick reference to resolved issues.
11. Ensure the maintenance of FDA Information Requests log for A/NDAs in an easily searchable format to provide insight into FDA review trends.
12. 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.
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