Job Title:Clinical Development and Regulatory Affairs Manager
Job Level: Manager
Reports to:Director, Regulatory Affairs and Head of Early Phase Development
Transpire Bio is a team of dedicated professionals with expertise in delivering medicines to the body through the inhaled route. The leadership team has over 100 years of experience in developing inhaled medicines and bringing these medicines to the US and European markets. Our purpose at Transpire Bio is framed by two core elements: Access and Innovation.
The Clinical Development and Regulatory Affairs Manager will have a dual role, supporting both the Clinical Development and the Regulatory Affairs departments at Transpire Bio Inc. (TBI).
The Clinical Development and Regulatory Affairs (CDRA) Manager will support clinical development programs while ensuring compliance with pharmaceutical industry regulations. They will be responsible for assisting Clinical Development (CD) and Regulatory Affairs (RA) leadership in the development and progression of clinical studies and regulatory submissions across all phases of research.
In support of the clinical development role, the position will assist in planning and execution of clinical studies, under the supervision of a Head of Early Phase Development, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. In support of the RA role, this position involves managing regulatory submissions, ensuring adherence to regulatory guidelines, cGMPs, ICH, and regulatory compliance, and collaborating with internal teams to support and facilitate drug development, and ensuring successful regulatory approval processes.
The ideal candidate will have a thorough understanding of both clinical development, and regulatory affairs practices related to the drug approval process including dossier submissions, excellent leadership skills, and a proven history of successful regulatory submissions and interactions with regulatory agencies.
Essential Duties and Responsibilities
- Support clinical and regulatory strategies for product development, product modifications, and lifecycle management.
- Monitor and interpret regulatory changes and trends to ensure ongoing agreement with regulatory guidance.
- Oversee clinical trials, ensuring adherence to Good Clinical Practice (GCP) and applicable regulatory requirements.
- Document Management:Maintain regulatory filings, maintain and review clinical trial documentation (e.g., CRFs, DMP, protocol training slides, etc.), and submission records.
- Stakeholder Collaboration:Liaise with internal teams, external regulatory agencies, and clinical sites to ensure smooth study execution.
- Risk Assessment: Identify potential compliance risks and develop mitigation strategies.
- Training & Education: Provide guidance on regulatory changes and best practices for internal teams.
- Data Analysis & Reporting: Support the collection and analysis of clinical data, ensuring accuracy and completeness in reporting.
- Assist in drafting, reviewing and updating clinical development and regulatory affairs SOPs
- Responsible for organizing, communicating and evaluating team objectives for clinical studies and timeline management
- Responsible for formatting requirements of clinical trial documentation and transmittal of trial and study-level documents to the Trial Master File
- Assist with the submission of relevant study-level documents to the company's shared server for study report use.
- Provides support for clinical and regulatory vendor selection
- Distribute key study documents to medical writers and vendors as appropriate
- Co-lead meetings with vendors as appropriate and assist with documentation of project-related meetings
- Manages collaborations and relationships with external partners/vendors
- Collaborate with cross-functional stakeholders on the execution of clinical development and regulatory affairs deliverables
- Provide clinical development and regulatory affairs administrative support. This may include preparing meeting logistics, distributing agendas, and minutes for study team meetings, and meetings with vendors
- Management of study project (s) within a program as single point of accountability for the delivery of study-related tasks, and maintains a strong working knowledge of protocols for assigned projects
- Contribute and author documents for IND/NDA/ANDA/CTA and other clinical (e.g., informed consent forms, clinical study reports, safety reports), regulatory documents (e.g. briefing documents, protocols, IBs), preparation and/or review of any documents related to clinical study drug development requiring a clinical or regulatory background
- Assist in preparing medical or scientific information/documentation/analysis when appropriate for protocol preparation or regulatory submissions
- Assist in the development and revision of annual, interim, and final reports and clinical sections of Pre- or Post-Market Approval submissions
- Work with the supervisors to provide input into the individual career development plan
Qualification Requirements.
- Bachelor’s degree in a scientific discipline; advanced degree preferred.
- Minimum 5+ years of experience in clinical research and regulatory affairs within the pharmaceutical industry.
- Experience with asthma and/or COPD clinical trials is highly preferred
- Proven experience with regulatory submissions.
- Clinical drug development, regulatory processes, and understanding of the design and conduct of clinical trials and regulatory submissions.
- Self-starter with experience working independently
- Quality-focused and well-organized
- Effective leadership, communication (verbal and written), and interpersonal skills.
- Ability to work effectively in a fast-paced and dynamic environment.
- Excellent organizational and project management skills.
- Demonstrates flexibility and adaptability
- Ability to travel up to 20% of the time as required
- Ability to work US standard Eastern time zone work hours preferred
- Ability to synthesize scientific information clearly and concisely, good presentation skills
- Ability to anticipate and timely escalate issues and to define appropriate action plans
- Familiarity with medical terminology.
- Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook
