Careers

We are seeking a highly skilled and detail-oriented Regulatory Scientist to join our regulatory team. This role is crucial in the preparation, submission, and management of Investigational New Drug (IND) applications and New Drug Applications (NDA) to the FDA. The ideal candidate will have a strong understanding of regulatory requirements, excellent project management skills, and the ability to collaborate effectively with clinical development, quality assurance, and CMC teams.

Regulatory Strategy Development:

1. Develop and implement regulatory strategies and health authority engagement plans for drug development.

2. Provide regulatory guidance throughout the drug development lifecycle, from preclinical to post-marketing.

3. Assess regulatory risks and develop mitigation strategies to support program success.

IND/NDA Preparation and Submission:

1. Lead the preparation and submission of IND and NDA applications, ensuring compliance with FDA requirements and adherence to submission timelines.

2. Work closely with clinical, non-clinical, and CMC teams to compile regulatory documentation, including clinical study reports, pharmacology, toxicology, and CMC data.

3. Establish and maintain submission timelines, ensuring alignment with regulatory and project milestones.

Regulatory Compliance and Monitoring:

1. Stay current with FDA regulations, guidance documents, and industry standards to ensure compliance and inform strategic decisions.

2. Monitor changes in regulatory requirements and assess their impact on ongoing and future projects.

Liaison with Regulatory Agencies:

1. Serve as the primary contact for the FDA and other regulatory agencies during the IND/NDA submission process.

2. Prepare for and participate in regulatory meetings, including pre-IND and pre-NDA meetings.

3. Address agency inquiries and coordinate responses to requests for additional information.

Cross-Functional Collaboration:

1. Work closely with clinical, non-clinical, CMC, and quality assurance teams to ensure regulatory compliance across all aspects of drug development.

2. Facilitate cross-functional communication to ensure timely and accurate submission of required data and documentation.

Post-Submission Activities:

3. Support post-submission activities, including responding to FDA queries, preparing for advisory committee meetings, and managing labeling and promotional materials.

4. Assist in the preparation of annual reports and other regulatory filings as required.

Education:

1. Master's degree in life sciences, pharmacy, or a related field (Ph.D. preferred).

Experience:

1. Minimum of 5 years of experience in regulatory affairs.

2. Proven track record of successful FDA submissions and regulatory agency interactions.

Knowledge and Skills:

1. Deep understanding of FDA regulations, guidance documents, and the drug development process.

2. Strong analytical skills with the ability to interpret complex regulatory requirements.

3. Excellent written and verbal communication skills for effective engagement with cross-functional teams and regulatory agencies.

4. Strong project management abilities, capable of handling multiple projects and deadlines in a fast-paced environment.

5. Proficiency in Microsoft Office Suite and regulatory submission software.

Personal Attributes:

1. Highly detail-oriented with a commitment to quality and regulatory compliance.

2. Ability to work independently while also being an effective team player.

3.Strong problem-solving skills with a proactive approach to challenges.

We are seeking a highly organized and experienced Clinical Operations Manager to join our dynamic clinical research team. The ideal candidate will possess a robust background in managing clinical trials, particularly in the areas of nephropathies, including IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), and other related kidney diseases. This role will involve overseeing the planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements, and maintaining high standards of quality throughout the trial lifecycle.

Clinical Trial Management:

1. Lead the planning, execution, and monitoring of clinical trials focused on nephropathies, ensuring that all activities align with the study protocol, timelines, and budgetary constraints.

2. Develop and implement comprehensive clinical trial protocols, informed consent forms, and case report forms, ensuring clarity and compliance with Good Clinical Practice (GCP) and regulatory guidelines.

3. Coordinate with cross-functional teams to ensure that all aspects of the trial are executed efficiently, including site selection, patient recruitment, and data collection.

Site Management and Monitoring:

1. Identify, select, and manage clinical trial sites, ensuring that sites are adequately trained and equipped to conduct the trials effectively.

2. Conduct regular site visits to monitor trial progress, assess site performance, and ensure compliance with study protocols and regulatory requirements.

3. Address any site-related issues promptly and implement corrective actions as necessary to maintain trial integrity.

Collaboration with Cross-Functional Teams:

1. Work closely with clinical research associates, data management, regulatory affairs, and medical affairs teams to facilitate seamless trial execution and data integrity.

2. Foster strong relationships with investigators, site staff, and key opinion leaders in nephropathies.

Data Management and Reporting:

1. Oversee data collection processes to ensure the accuracy, completeness, and integrity of clinical trial data.

2. Prepare and present trial updates, interim analyses, and final reports to stakeholders.

3. Collaborate with biostatisticians to ensure appropriate statistical methodologies are applied to study design and data analysis.

Regulatory Compliance:

1. Ensure that all clinical operations activities comply with FDA, EMA, ICH guidelines, and company policies.

2. Support regulatory submissions (INDs, NDAs) and respond to regulatory inquiries as needed.

Budget Management:

1. Assist in developing and managing clinical trial budgets.

2. Ensure accurate tracking of expenditures and timely payments to sites/vendors.

Education:

1. Bachelor's degree in life sciences, nursing, or a related field (MS preferred).

Experience:

1. 10+ years of experience in clinical operations (nephropathy experience preferred).

2. Proven track record in trial management, site monitoring, and regulatory compliance.

Skills & Attributes:

1. Strong project management, organizational, and problem-solving skills.

2. Proficient in clinical trial management software and data analysis tools.

3. Excellent communication and collaboration skills.

4. Detail-oriented, proactive, and able to manage multiple projects effectively.