The Senior Manager, Regulatory Operations will be responsible for overseeing operational aspects of all regulatory submissions, ensuring that the submissions are of highest quality, delivered on-time, and within established budget. The position is also responsible for overseeing the effective and appropriate management and archiving of regulatory documentation. Emphasis will be on proper planning, management, and superior execution on all aspects of regulatory affairs operations.
Manage document publishing for regulatory submissions from all areas of the company, in support of active INDs, (e.g. clinical trial applications, IND/ODD annual reports, amendments); may include both paper and e-filings.
Manage publishing activities for marketing applications (original applications, supplements, advertising transmissions, periodic reports) in eCTD format (formatting, publishing, submitting, life-cycling, and archiving sequences).
Oversee the management of electronic and/or paper-based regulatory records.
Provide recommendations on resource needs for regulatory operations and records management activities including the need for outsourcing (e.g., eCTD vendor, SPL vendor).
Provide oversight for the selection and management of any outsourced publishing and records management vendors.
Create and manage submission plans in conjunction with Regulatory colleagues.
Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities.
Manage selection, implementation, validation (as applicable) and maintenance of IT tools for regulatory team.
Develop proposals for continuous improvement of internal systems and processes related to publication, submissions, and archiving of regulatory dossiers in a secure and readily-accessible manner.
Apply knowledge of electronic publishing requirements to ensure compliance with agency submission requirements and remain current with evolving standards for electronic submissions and inform other staff of these standards.
Qualifications and Experience:
Bachelor’s degree with a minimum of 8 years’ experience in a Regulatory Operations role.
Demonstrated experience in project management and clear understanding of US and ex-US requirements with respect to submission content and format/knowledge of industry trends in dossier preparation. (i.e.: IND/CTA/BLA/NDA/MAA).
Demonstrated expertise with submission publishing tools (eCTD building tools), Regulatory Information Management, and content/document management tools.
Ability to work independently with moderate supervision; ability to communicate and interact with a variety of personnel, including management and external vendors; ability to direct operational staff to achieve submission publishing timelines successfully.
Excellent organizational skills, sufficient to multi-task and manage project timelines in an extremely fast-paced environment with changing priorities.
Knowledge expert regarding global regulatory submission standards, software validation concepts, and publishing best practices.
Excellent knowledge of Word and Adobe Acrobat Pro required.
Experience in collaborating with Regulatory Affairs on program development strategy and communication with regulatory agencies a plus.
Excellent team building, leadership and management skills.
Excellent listening, communication and interpersonal skills fostering team spirit.
Consistent delivery of high quality work at all times.
Outstanding skills in managing vendors and others involved in regulatory operations activities to meet corporate objectives.
Ability to accurately project timelines, budgets and manage them across studies and projects.
Internal Number: 1
About Kiniksa Pharmaceuticals
We are a privately-held clinical-stage biopharmaceutical company focused on discovering or acquiring, developing, and commercializing therapeutic medicines for patients suffering from devastating and debilitating diseases with significant unmet medical need. We have built a pipeline of product candidates across various stages of development, currently focused on autoinflammatory and autoimmune diseases. We have three clinical-stage product candidates, one of which is anticipated to commence a Phase 3 clinical trial in 2018. We have recently raised an additional $200M from new and existing investors, bringing the total to $320M since our inception in late 2015.
At Kiniksa, we are focused on hiring and retaining a highly skilled team that has extensive experience and specific skill sets relating to the selection, development, and commercialization of transformative therapies. Whether in development, research, manufacturing, technical operations, or general / administrative functions, we depend on a talented team to support our mission of building a global, generational company.
Our benefits are competitive, and we offer dynamic career opportunities across our organization fost...ering a culture that embraces passion and rapid execution.
Development Asset Details:
•Subcutaneously administered cytokine trap that inhibits the signaling of two soluble cytokines (product is already FDA approved via partner in alternative indication)
•Plan to initiate a Phase 3 trial in a rare, inflammatory cardiovascular disease where there are no currently approved therapies in 2018
•Monoclonal antibody inhibitor of a key growth factor for cells of myeloid lineage, licensed from global biopharma company
•Hundreds of patients’ worth of data in a large autoimmune condition through phase 2b with demonstrated competitive efficacy and safety profile
•Kiniksa plans to initiate a Phase 2 study in rare, inflammatory vessel disease
•Monoclonal antibody inhibitor of two key cytokines involved in pruritus, barrier dysfunction and fibrosis
•Recently completed enrollment in a Phase 1b study in subjects with cutaneous inflammatory disease which may provide both safety and efficacy data in the near-term
•Plan to initiate two proof-of-concept studies in inflammatory pruritic conditions in 2018
•Monoclonal antibody inhibitor of a key T-cell co-stimulatory pathway involved in T-effector memory cell function
•Plan to submit an IND in 2019
•Monoclonal antibody inhibitor of a central control node of T-cell dependent, B-cell mediated humoral adaptive immunity
•Plan to submit an IND in 2019
•Multiple ongoing discovery-stage projects