Sr. Scientist, Regulatory Affairs & Product Development (Non-Clinical Submissions)

What Regulatory Affairs and Product Development contributes to Cardinal Health
Regulatory Affairs & Product Development is responsible for clinical development, nonclinical development, and regulatory affairs consulting to provide innovative solutions and regulatory submissions for all aspects of pharmaceutical, biologics and device development from discovery through post-approval maintenance. This position is a Non-Clinical Submissions Strategy and Author role.

Location - Fully remote (work hours will be 8am - 5pm in whatever time zone the individual resides)

Responsibilities

Individual will be responsible for production of the desired submission documentation, utilizing
specified templates, formats, and databases and within agreed-to timelines for various
nonclinical components, including, but not limited to, the following submission types:

• Clinical trial applications and amendments
• Nonclinical sections (Module 1, Module 2, Module 4) of registration dossiers (US, EU, other regions), including preparing international marketing applications (eg, International Registration Dossiers, NDS, BLA, and JNDAs) from initial CTDs
• Annual Reports (IND, NDA, Canada YBPR)
• Post Approval Supplements and Variations, Renewals, and Assessments for compliance

Nonclinical activities may include, but are not limited to, the following:

• Using nonclinical templates and source documentation from the technical teams, prepare or author nonclinical sections, including nonclinical reports, (Module 1, Module 2, and Module 4) for clinical trial applications and amendments, registration dossiers, annual reports, and post-approval variations and renewals.
• Prepare and update nonclinical sections of Marketing Applications and Authorizations.
• Develop nonclinical regulatory strategies for product development for global products.
• Develop nonclinical regulatory post-approval filing strategies and variations for global products.
• Prepare nonclinical sections for US Annual Reports or DSURs; ensure that regulatory documents are prepared accurately, completely and on time.
• Prepare responses to Health Authority queries and requests for nonclinical information.
• Perform regulatory authority inspection readiness audits of client or vendor systems and facilities.
• Perform vendor qualification audits and/or study monitoring on behalf of clients.
• Maintain fluency in emerging global nonclinical regulations.
• Liaise with clients on technical details of the submission or project as required.
• Activities may include submission-specific strategy development in collaboration with clients.
• Liaise with clients for overall project management/relationship management.
• Data verification of nonclinical submission sections prepared by CHRS against verified source documentation.
• Data verification of nonclinical submission sections prepared by clients.

Client will provide verified source documentation. Dossier conversion of older submissions may be requested. These activities include:

• Using a roadmap that defines where the content from an older submission should be placed in the CTD structure along with readily available regulatory guidance documents, text is moved, copied, or re-keyed from one location to another and formatted accordingly.
• The submission, when formatted to contemporary standards, will have "gaps" which will need to be filled by using data from reports or other substrate and authoring of text to put the data in context.
• Review/Assess dossier against contemporary regulatory compliance standards, including recommendation of alternative approaches (and success assessment) to address data gaps. Scientific justifications may need to be prepared to address some gaps which the client may decide to accept and not fill.
• Verification of document manipulation step against the source document for proof-reading, transcription, and OCR accuracy prior to dossier analysis and completion step.

Qualifications

• 5+ years of nonclinical regulatory experience with demonstrated project management, interpersonal, and leadership skills, all preferred
• Bachelor’s degree in a scientific discipline (eg, chemistry, pharmacy, biology);
  advanced degree (both preferred)
• Advanced knowledge of global nonclinical regulations and guidelines (Module 1, Module 2, and Module 4)
• Strong knowledge in global post-approval nonclinical change regulations, and in the content and structure of the nonclinical section of a Marketing Authorization.
• Broad functional knowledge of pharmaceutical sciences and clear understanding of drug
  development or manufacturing/improvement processes
• Excellent communications skills (both written