Senior Director, Regulatory Affairs
Abata TherapeuticsSalary not specified
Senior Manager, Regulatory Affairs at Eikon Therapeutics
Jersey City, New Jersey, United States
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biopharmaceutical, BiotechnologyIndustries
Requirements
- Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant scientific discipline
- Strong knowledge of FDA and international regulatory requirements and guidelines
- Excellent communication, negotiation, and project management skills
- Ability to work effectively in a cross-functional team environment
- Attention to detail, strong analytical skills, and problem-solving abilities
- Adaptable and able to thrive in a fast-paced, high-growth environment
- Minimum of 3 days a week onsite presence in Jersey City (NJ) office (or more as business needs require)
Responsibilities
- Execute regulatory strategies to support product development, approval, and commercialization, ensuring alignment with the company's goals and objectives
- Stay current with all relevant regulations, guidelines, and industry best practices; ensure company activities and products adhere to applicable regulatory requirements
- Prepare, review, and submit regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs)
- Collaborate closely with R&D, Quality Assurance, Clinical Development, and other teams to provide regulatory guidance and integrate regulatory considerations into product development
- Oversee regulatory aspects of quality systems, including compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP)
- Identify and evaluate regulatory risks associated with projects and provide solutions to mitigate those risks
- Act as the primary contact with regulatory agencies for effective communication and negotiation
Skills
Regulatory Affairs
FDA Regulations
International Regulatory Requirements
Regulatory Compliance
Submission Management
Project Management
Cross-functional Collaboration
Negotiation
Analytical Skills
Eikon Therapeutics
Biotech startup developing innovative medicines
About Eikon Therapeutics
Eikon Therapeutics focuses on discovering and developing new medicines in the pharmaceutical industry. The company employs advanced technologies to study biological systems, aiming to identify new drug targets by examining the dynamic aspects of biology rather than just static chemical processes. Their team consists of diverse professionals, including data scientists, chemists, and engineers, which allows them to combine science and engineering to create new therapies that aim to improve and extend life. A key feature of Eikon's approach is their proprietary single-molecule tracking (SMT) platform, which enables rapid visualization of protein movements in living cells. This technology, along with artificial intelligence and automation, allows for precise inventorying of molecular interactions. Eikon Therapeutics targets patients with serious diseases who need effective treatments, generating revenue through the development and commercialization of their therapies.
Hayward, CaliforniaHeadquarters
2019Year Founded
$750.8MTotal Funding
SERIES_CCompany Stage
AI & Machine Learning, BiotechnologyIndustries
201-500Employees
