Sr. Associate, Global Regulatory Operations

Apellis Pharmaceuticals, Inc. Waltham , MA 02154

Posted 6 months ago

Position Summary:

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.

Principal Responsibilities:

  • 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

Qualifications:

  • 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

Education:

  • A minimum of a Bachelor's degree in a scientific or technical discipline is required; equivalent experience may be accepted. Masters degree preferred
  • A minimum of 4 years pharmaceutical or other related industry experience with 2-3 years of regulatory submission management experience

Competencies:

  • 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.

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.

Visit http://apellis.com/about.html to learn more.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr RA/ Associate Scientist Muscle Cell Biology

Apex Systems

Posted 3 days ago

VIEW JOBS 11/10/2019 12:00:00 AM 2020-02-08T00:00 Job Description Job #: 989475 Senior Research Associate, Muscle Cell Biology, 989475 Job Scope & Purpose: Our Cambridge/Greater Boston area client has been making a splash in the local biotech scene and is looking to add a motivated biologist to work on cellular/molecular assays as part of the discovery team. This is an exciting, well-funded, emerging company seeking an exceptional Sr. RA muscle/neurobiologist to support a first in class platform for rare disease therapeutics. If you are skilled in the techniques below this is your opportunity to make a considerable impact and get in at the ground floor of a promising company with proven leadership. This role will move quickly, message us for more details! Primary Job Responsibilities: * Establish cell-based assays, specifically muscle cell types, to support cutting edge drug discovery programs. * Execute research plans for in vitro studies * Analyze data and communicate findings to team members and management. * Contribute to critical discussions of experimental design and assay development Primary Job Requirements: * BS or equivalent in a biological discipline and 2-5 years of hands on experience in drug discovery and development. * Strong expertise working with primary cell culture, specifically muscle or neuro * Experience with molecular biology techniques such as DNA and RNA extraction, qPCR, Western blot, and ELISA a plus * Ability to effectively communicate ideas and document research. * Experienced in software applications (Prism, Excel, PowerPoint). About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. [ Link Removed ] [ Link Removed ] Code: DiscDevt EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [ Phone number blocked ] -6178. Apex Systems Waltham MA

Sr. Associate, Global Regulatory Operations

Apellis Pharmaceuticals, Inc.