Manager, Regulatory System Business Support

Regulatory Affairs Waltham, Massachusetts


Description

The Manager, RSBS will be involved in managing routine support activities including ensuring that user accounts are created and kept updated; training logs are up to date; controlled vocabularies & dictionaries are kept updated and in compliance with relevant pharmacopoeia/standard terms, etc.

The Manager, RSBS will review, prioritize, track and respond to user issues, service requests and inquiries, and will collaborate with IT in solving more technical user issues. The role will also have direct daily contact with global users supporting their efficient and compliant use of the RA systems. The role supports and has a key role in assisting with business analysis and implementation of changes and new processes and has solid understanding of business change management principles. The role will be the main contact with vendors and service providers on systems related upgrades and issues and will mentor and train junior members of the GRO team, as needed.

Key Responsibilities

  •  Administer end-user accounts and ensure appropriate access control/permissions
  • Provide support to global end-users by understanding and ensuring their needs are met and escalating more complex queries and issues
  • Establish and maintain effective communication with end-users and other key stakeholders
  • As an expert in RA Technology Systems functionalities, plan, manage and deliver end user training to groups or individuals, as needed
  • Lead activities related to setting standards, best practices, KPIs collection, developing new procedures and work instructions, and lessons learned dissemination
  • Business lead for design, selection, and implementation of Apellis’s (Regulatory) electronic document management system (EDMS) and manage workflows and templates.
  • Participate in systems maintenance activities ensuring the systems always remain in a validated state
  • Lead activities related to upgrades and maintenance of regulatory systems to ensure successful deployment
  • Main contact with vendors and service providers on systems related issue resolution, maintenance and upgrades.
  • Monitor the development of new regulatory requirements or guidance, and provide advice to GRO and GRA of the impact on the business
  • Responsible for communicating system status and maintenance activities and liaise with IT and vendors on extended support, hyper care, business continuity and disaster recovery
  • Assists with other GRO activities, as needed.


Education, Registration & Certification:

A minimum of a bachelor’s degree in a scientific or related technical discipline is required; equivalent experience may be accepted.

Experience:

  • 5+ years of experience in Global Regulatory Affairs or Regulatory Operations within the pharmaceutical industry, with 3 years business systems support experience.
  • General knowledge of drug development and pharmaceutical industry standards (Pharmacopoeia, Standard Terms, ISO, MedDRA, SNOMED, etc)
  • Demonstrated experience managing, developing and administering electronic document management systems (eg Veeva, SharePoint), regulatory publishing systems and regulatory tracking databases
  • Working knowledge of SW system validation process and compliance concepts
  • Solid experience regulatory publishing systems and/or regulatory tracking databases and maintenance of their dictionaries and controlled vocabularies
  • Strong presentation and communication, and follow-up skills
  • Strong knowledge of GxP, Annex 11 and 21 CFR Part 11 computerized systems
  • Expert in MS Office Tools, Visio and Starting Point templates
  • Experience of providing direct end-user support, training and service
  • Team player with excellent interpersonal skills
  • Knowledge and working experience with eCTD Validation tools (Lorenz eValidator, ARIM Validator, etc.) and other publishing and QC tools (PDF Tools, ISIToolbox, etc.)
  • Working experience with Acrobat-based and DocuSign electronic signature systems
  • Prior experience with implementation and utilization of submission gateways (ESGs)
  • Experience with other systems, eg, eTMF, PV, EDC, CTMS, QMS, AdPromo, Labeling is a plus, and working knowledge of SharePoint is desirable
  • Able to simultaneously manage multiple projects
  • Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities.

Skills, Knowledge & Abilities:

  • Working knowledge of EDMS, experience with regulatory submissions and publishing systems, and working knowledge of information tracking and submission gateway systems
  • Strong knowledge of the global eCTD structure and requirements, and familiarity with submission and drug development dossier concepts
  • Strong organizational and project management skills
  • Ability to express oneself clearly and concisely to a variety of audiences
  • Great interest and ability for training
  • Good knowledge and understanding of the pharmaceutical industry and pharmaceutical companies’ operations processes and strategies
  • Ability to lead cross-functional and cross regional teams and deliver results in a fast-paced environment
  • Strong desire in learning about Regulatory Affairs as well as understanding of European, US and other regulations with regards to activities covered in regulatory operations.

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.

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.