Apellis is offering an opportunity for a motivated Life Sciences professional to join our team, as a Senior Associate of Global Regulatory Operations. The Sr Associate, Global Regulatory Operations, is accountable for managing the routine and non-routine submission activity for Apellis' portfolio. The Sr Associate, in collaboration with the Regulatory Lead, plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities on a timely manner. The Sr Associate provides technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submissions, and will act as the primary point of contact for project and/or submission teams for major submissions. The Sr. Associate will also support the Global Regulatory Operations Head or other members of the Regulatory Affairs, in activities related to setting standards, best practices, collection of metrics, developing new procedures and work instructions, and lessons learned dissemination and will assist in other activities as needed. It is expected that Sr Associate, will be significantly involved in publishing activities and will contribute to archiving activities of the Group, along with implementation of systems and tools.
Provides operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (IND, NDA, MAA, etc.), updates, amendments, and variations to global regulatory agencies
Monitors the development of new regulatory requirements or guidance documents and provides advice to Global Regulatory Operations and project teams of the impact on the business
Involved in development and implementation of standards for dossier management, publishing, archiving and submission process for global regulatory authorities
Participates in validation activities (requirements gathering, User Acceptance Testing, etc.) for the implementation of technology systems (Publishing, EDMS, etc.)
Participates in compliant and timely archiving of regulatory submissions and correspondences for Apellis compounds
Works closely with CROs and publishing vendors in preparation of high-quality submission packages and their timely delivery to health agencies
Is involved in regulatory submission process improvements activities and establishing standard processes using appropriate tools, processes and best practices
Responsible for management of the cross-functional global submission teams in the delivery of compliant submission components according to agreed standards, requirements, timelines and processes. This includes support with planning and presenting at project 'kick-off' meetings and preparing appropriate materials to facilitate team discussion, timeline mapping and submission strategy
Participates and shares lessons learnt sessions to encourage process improvement and efficiencies within and across submission project teams
Negotiates and agrees on realistic dates for document hand offs in collaboration with the authors and publishers (in-house and vendors)
Performs publishing and dossier compilation of routine and non-routine eCTD and other submissions, as needed (and as assigned)
In collaboration with the regulatory lead, manages the development and maintenance of a global submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and QC
As a global submission's expert, ensures the project team has sufficient awareness and knowledge of e-submissions (eCTD, NeeS, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation
Manages updating and distribution of the Global Submission Planner and Tracker information
A minimum of 4 years of experience in regulatory affairs/operations within the pharmaceutical industry
Prior publishing and archiving experience is required
Strong verbal and written communication and presentation skills. A strong training skill is a plus
Strong interpersonal skills and ability to build relationships with cross-functional teams
Highly knowledgeable in CTD/eCTD structure and requirements and a very good understanding of submission requirements for global submission types (e.g. IND, NDA, MAA, NDS, CTA, PSUR etc.)
Solid experience in publishing and compilation of eCTD submissions for US and EU filings is required and experience publishing electronic submissions in other regions is desirable
Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (PDF Tools, ISIToolbox, etc), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools. Solid experience and knowledge of SharePoint technology is desired
In-depth knowledge of StartingPoint templates. Will act as a trainee for new users
Demonstrated project management, organizational and planning skills
Ability to multi-task, attention to details, and end-result driven with meeting deadlines
Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities
Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines
Good understanding of submission deliverable dependencies and ability to reflect this in project plan in order to create and maintain detailed submission schedules (as MS-Project tasks)
Good understanding of the internal and external inter dependencies among submission activities that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are met on a timely manner and to the highest quality
Experience of working external publishing vendors desired
Excellent experience and expertise with electronic publishing (eCTD) software, submission planning and tracking tools and concepts, and content/document management tools
Familiarity and experience with Regulatory Information Management concepts and tools is preferred
Familiarity with submission and drug development dossier concepts
A very strong understanding of the global eCTD
Good organizational and project management skills
Good knowledge of quality control procedures and methods related to processing of electronic and paper submissions, when needed
Solid experience in the organization and management of electronic and paper archival file records for correspondence with regulatory agencies, formal submissions, etc
Great interest and ability for training
Physical Demands and Work Environment:
This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.
This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Benefits and Perks:
Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit http://apellis.com/careerbenefits.html to learn more.
We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.
Visit http://apellis.com/about.html to learn more.
Apellis Pharmaceuticals, Inc.