Position – Clinical & Regulatory Affairs Manager
The Clinical & Regulatory Affairs Manager will have responsibilities and use their experience to support both regulatory and clinical operations. The successful candidate will assist with preparation, review, and submission of both regulatory and clinical site-related documents as required to support multiple products for multiple indications. Experience with the content of regulatory submissions to FDA and with clinical operations-related activities is a must.
Facilitate production of submissions including pre-IND, IND, and amendments of all types
Track and assure proper maintenance of open INDs
Advise on and aid in the planning and oversight of clinical and regulatory activities
Research regulatory issues
Critically review clinical trial and regulatory-related documents, procedural plans, protocols, and reports, to ensure suitability for use and/or submission to regulatory agencies.
Participate in CRO and site management
Other duties as assigned
Bachelor’s or Master’s degree in the Life Sciences. PhD is a plus.
Experience an skills:
Must have experience with preparing, submitting, and maintaining a CTD-formatted IND
Experience with clinical product development in industry (biotech or pharma) is preferred
Hands on experience participating in trial start-up and management
Strong document editing skills
Experience with development of drug or biologic-based therapeutics is a must (experience cannot be exclusively device or diagnostic)
Individuals with background as PM, CRA, or Regulatory Affairs associate/scientist will be considered if experience or demonstrated aptitude covers the stated responsibilities
Position – CMC lead
The right candidate will serve as the primary contact for CMOs and CROs on all aspects of manufacturing such as establishing contract documentation, overseeing manufacturing, release and characterization of proprietary Neuraly products. This role requires oversight and direction in all manufacturing operations as well as sufficient technical and regulatory knowledge to assure appropriate processes and adequate testing. This includes bulk drug substance (upstream / downstream), fill-finish, analytical, formulation and stability for Phase 1 and Phase 2.
Official title TBD based on experience.
Assure appropriate manufacturing scale, quality and timeline to meet FDA requirement and corporate milestones.
Provides input to technical development to establish early product definition, including process development, formulation, analytical development and delivery, and to ensure facility/operational considerations are factored into process decisions.
Drives compliance with regulatory and quality, prepares and reviews regulatory filings and submissions (IND, Annual reports and other regulatory documents as required), inventions disclosures, progress reports and publications.
Leads investigations of deviations and oversees root cause analyses to identify.
Identifies and communicates risks in area of responsibility.
Contributes to the Company’s annual budget and quarterly forecasting processes.
Develops and maintains comprehensive project plans and budgets for CMC programs.
Serve as an internal resource for R&D regarding manufacturing science, analytical, formulation and delivery issues.
Degree in Chemical Engineering, Molecular Biology, Analytical Chemistry, Pharmaceutical Sciences or equivalent.
Experience and Skills:
8+ years’ experience in cGMP manufacturing of peptide products or small molecules through Phase 1/2 development.
Knowledge of biologics manufacturing is a plus.
Analytical and CMC development experience
Knowledge of technical/regulatory requirements for Phase 1 and Phase 2 clinical products
Experience leading or overseeing manufacturing from lead development through early-stage clinical is preferred.
Experience with vendor management and technology transfer
Knowledge of analytical techniques, formulation development and stability testing.
Understanding of project management principles applicable to bio/pharma.
Demonstrated ability to balance scientific, technical and business objectives
Strong collaborative skills, ability to develop working relationships at all levels of the organization
Strong written, verbal, quantitative and analytical skills along with strong attention to detail.
Candidate should feel comfortable working in a start-up environment and be able to work overtime when needed