Senior Director, Regulatory Affairs
Abata TherapeuticsSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- Bachelor’s degree in life sciences or a related field; advanced degree (PhD, PharmD, or MS) preferred
- Prior experience as a Global Regulatory Lead (GRL) preferred
- 10+ years of experience
Responsibilities
- Develop and implement regulatory strategies for clinical stage programs, ensuring alignment with business and development objectives
- Serve as the primary Regulatory Affairs representative on project teams, providing guidance on regulatory requirements and pathways
- Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, CTAs, amendments, briefing packages, and responses to health authority inquiries
- Manage interactions with FDA and other global regulatory agencies; coordinate and prepare for regulatory meetings
- Partner with CMC, Nonclinical, and Clinical teams to ensure compliance with applicable regulations and consistent messaging across submissions
- Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies
- Monitor the evolving regulatory landscape and communicate implications for Septerna’s programs
- Support the development of internal regulatory processes, systems, and documentation to enable scalability as the organization grows
- Mentor and develop junior regulatory staff and contribute to a culture of collaboration and excellence
Skills
Regulatory Affairs
GPCR Drug Discovery
Preclinical Development
Biotechnology Regulations
Therapeutic Development
Superna
Data protection solutions for Dell EMC Isilon
About Superna
Superna Eyeglass provides data protection solutions specifically designed for Dell EMC Isilon storage systems. Their products include tools for data replication, disaster recovery, and compliance auditing, which help enterprise clients manage their data securely and efficiently. The software operates on a subscription model, allowing clients to receive regular updates and technical support. What sets Superna Eyeglass apart from competitors is its focus on the unique needs of Dell EMC Isilon users, enabling them to offer specialized services in the data protection market. The company's goal is to ensure that clients can maintain secure operations while meeting compliance requirements.
Ottawa, CanadaHeadquarters
2002Year Founded
BUYOUTCompany Stage
Data & Analytics, Enterprise SoftwareIndustries
51-200Employees
Risks
Emerging startups offer innovative solutions at lower costs, threatening market share.
Cloud-native solutions may outpace Superna's current offerings, reducing attractiveness.
Vulnerability in Dell EMC Isilon systems could impact client trust if not addressed.
Differentiation
Superna Eyeglass specializes in Dell EMC Isilon storage systems, carving a niche market.
The company offers a subscription model, ensuring ongoing software updates and support.
Superna provides tailored solutions for data replication, disaster recovery, and compliance auditing.
Upsides
Rising demand for hybrid cloud solutions boosts Superna's market potential.
New data privacy regulations increase demand for compliance auditing tools.
Ransomware threats drive demand for robust disaster recovery solutions.
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