Design Space InPharmatics (DSI), a nation-wide Consulting group is seeking a Regulatory Author Consultant serving as the primary publisher of global Regulatory submissions. Consultant will be responsible for providing document and sequence level publishing and compilation for global regulatory submissions. The Candidate will work remotely in a team environment.
Role and Responsibilities
- Proactively interacts with multiple functions working with external partners to independently coordinate, review, and/or generation of all necessary CMC regulatory submission documents,
- Plan, schedule and coordinate regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements,
- Ensures timely delivery of high-quality CMC documents including, regulatory authority requests for information, IND/IMPD/CTA submissions, NDA /MAA/JNDA submissions, and DMFs while assuring all documents meet regulatory requirements and quality compliance,
- Works with Subject Matter Experts and document authors across all disciplines to develop and maintain a comprehensive set of eCTD submission document templates,
- Facilitates the development of all technically complex CMC documentation for submission to regulatory authorities,
- Articulates complex Regulatory CMC issues to internal project teams and external stakeholders to support global development and commercialization of drug candidates,
- Manages submission projects to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, amendments/supplements/variations, and other submissions which present CMC information,
- Maintains current understanding of the regulations and guidelines pertaining to CMC/Quality information relevant to DSIs clients development programs,
- Experience with electronic Common Technical Document (eCTD) publishers and templates,
- Supports DSI Management Team in the development of overall product development and registration strategy,
Qualifications and Education Requirements
- S. in a scientific discipline or an equivalent combination of education, training, and experience. Candidates must have a minimum of 5 years of experience in Regulatory CMC.
- Demonstrated ability to deliver high quality regulatory documents. Thorough understanding of the pharmaceutical industry and healthcare environment including regulatory requirements, guidelines, and market and policy trends,
- Must be capable of leading a team in preparation of complex regulatory submissions by providing document formatting support,
- Knowledge of eCTD publishing systems, EDMS technology and related publishing tools,
- Working knowledge of US FDA (OGD/CDER) e-submission requirements,
- Prior success filing IND/CTA/IMPD and NDA/BLA/MAA within timelines is required; global submission experience required,
- Manage document processing submissions with minimal supervision from senior management,
- Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities,
- Highly resourceful team-player, with the ability to be extremely effective independently,
- Strong negotiating skills: able to think creatively, develop creative solutions and effectively communicate solutions to stakeholders,
- PC literacy required; Proficient use of technology including MSOffice skills (Outlook, Word, Excel, PowerPoint, document management systems, and Internet resources is expected),
- Ability to travel up to 20% as required.
- The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. DSI reserves the right to change this description at any time and require the consultant to perform other tasks as required due to business needs,
- This is a great opportunity for someone who is looking to join a growing company that is the already the acknowledged market leader in the dynamic and expanding regulatory drug development services arena focusing on CMC,
- Candidate must have USA permanent work authorization. No sponsorship for work visas is available.
How To Apply:
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