Description
DESCRIPTIONManage clinical and nonclinical aspects for a Phase 3 development projects
RESPONSIBILITIES
- As part of a Regulatory team, manage clinical and nonclinical aspects for a Phase 3 development project
- Manages and develops regulatory strategies and plans to for timely approval of new products
- Develop and review regulatory files to ensure that all submissions are submitted with quality and timely urgency
- Actively participate in internal interdisciplinary teams providing Regulatory advice consistently
- Monitors and assesses Regulatory developments related to the Company's products
- Proactively identify issues and implement appropriate regulatory strategies to mitigate risks
- Ensure consistent and appropriate communication within the department and with other functional areas
- Interface with global Regulatory authorities, partners, and consultants
- Filing/managing IND/CTAs, annual reports in multiple countries for multiple protocols
- Preparation for and conduct of Agency meetings as necessary to support IND/CTA filings
- Planning and activities supporting future NDA filing
- Maintain vast knowledge of global policies, regulations, and guidance's governing drugs in every phase of development
EXPERIENCE
- Strong scientific background and at least five years of experience in Clinical Regulatory Affairs in the biotechnology or pharmaceutical industries
- BA/BS in life sciences required. Masters or additional degree desired
- Vast understanding of global drug development regulations and guidelines
- Proven ability to successfully manage submissions and critical projects to deadlines
- Excellent and written communication skills along with negotiation skills
- Ability to function within and lead interdisciplinary teams
- Problem-solve capable of identifying risks and implementing risk mitigation
To find out more about Real please visit www.realstaffing.com