Manager or Sr. Manager, Regulatory Operations

Regulatory Affairs Waltham, Massachusetts


Description

Apellis is offering an opportunity for a motivated Life Sciences professional to join our team, as a Manager/Senior Manager of Global Regulatory Operations.

Position Summary

The Mgr/Sr Mgr, Global Regulatory Operations, is accountable for managing the routine and non-routine submission activity for Apellis’ portfolio. The Mgr/Sr Mgr, 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 Mgr/Sr Mgr provides technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submissions, and acts as the primary point of contact for project and/or submission teams for major submissions. The Mgr/Sr Mgr will also support the Global Regulatory Operations Head or other members of the Regulatory Affairs, in activities related to setting standards, best practices, metrics collection, developing new procedures and work instructions, and lessons learned dissemination, and will assist in other activities as needed. It is expected that Mgr/Sr Mgr, will be deeply involved in publishing and submission management and will contribute to archiving and information management activities of the RA Department, along with implementation of systems and tools.

Key Responsibilities Include:

  • 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;
  • Plays a major role 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.);
  • Oversees compliant and timely archiving of regulatory submissions and correspondences for Apellis compounds and generation of KPIs;
  • Manages activities of the publishing vendors in preparation of high quality submission packages and their timely delivery to health agencies;
  • Manages 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;
  • Manages 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 handoffs 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 submissions 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.
  • Other duties as required.

Education, Registration & Certification:

  • A minimum of a Bachelor’s degree in a scientific or technical discipline is required; equivalent experience may be accepted. Master’s degree preferred.
  • A minimum of 6 years pharmaceutical or other related industry experience with 4 years of regulatory submission management experience

Experience:

  • A minimum of 6 years of experience in regulatory affairs/operations within the pharmaceutical industry;
  • Prior publishing and archiving experience is required;
  • Expertise in CTD/eCTD structure and requirements and an excellent understanding of submission requirements for global submission types (e.g. IND, NDA, MAA, NDS, CTA, DSUR, PSUR, REMS, 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;
  • Experience of working with external publishing vendors desired.

Skills, Knowledge & Abilities:

  • Excellent experience and expertise with electronic publishing (eCTD) software, submission planning and tracking tools and concepts, and content/document management tools;
  • Strong knowledge and experience with Regulatory Information Management concepts and tools is a must;
  • Expert in submission and drug development dossier concepts;
  • A Subject Mater expert in understanding of the global eCTD;
  • Superior 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 interdependencies 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;
  • Superior organizational and project management skills;
  • Excellent verbal and written communication and presentation skills. A strong training skill is a plus;
  • Very strong interpersonal skills and ability to build relationships with cross-functional teams;
  • Very strong 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!

Company Background:

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.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.