Sr. Manager, Regulatory Information Management (RIM)

Regulatory Affairs Waltham, Massachusetts


Description

This position leads the global Regulatory Information Management (RIM) activities, and in conjunction with the Head of GRO, is responsible for the RIM strategy for Regulatory Affairs Department, and accountable for implementation and management of regulatory information tools, processes and standards. The RIM Lead is the business lead for RIM system implementation projects and will collaborate with other members of GRO, ie, Regulatory Systems Business Support (RSBS) and Submissions Management (SM), in implementing, managing and stewardship of the regulatory archives and repositories.

The RIM Lead ensures close collaboration and strong relationship with all stakeholders including Information Technology (IT), Quality Assurance (QA), Pharmacovigilance (PV), Manufacturing, Clinical Operations, Nonclinical, in addition to all Regulatory sub-disciplines. The role will act as the main RA contact with other major stakeholders and users of the RIMS information, especially those involving Master Data Management (MDM) and Identification of Medicinal Products (IDMP). The RIM Lead plays a key role in setting standards, best practices, KPIs collection, developing new procedures, and dissemination of lessons learned, and will assist in other activities as needed.

Key Responsibilities

  • Responsible for developing processes for secure and consistent data entry, maintenance and periodic quality checks for data compliance;
  • Provide support, training and direction to global end users and ensure their needs are met;
  • Seek and compile user-group feedback, identify issues and improve data quality, and user satisfaction, to enhance system development and promote streamline processes;
  • Assist in developing regulatory information management landscape and related road map;
  • In collaboration with stakeholders, design, implement and disseminate standard, validated and ad-hoc reports, to meet regulatory and other compliance requirements;
  • Accountable for the maintenance of XEVMPD database for all Apellis’s investigational and (future) marketed products; business lead for the implementation of IDMP;
  • Manage and oversee development of training materials, ‘quick reference guides’, FAQs, Job Aids, and other reference documents, describing system related business processes;
  • Responsible for creation and management of dictionaries/libraries for RIM systems and best strategies for the adoption of controlled vocabularies and their harmonization across systems;
  • Responsible and accountable for implementation of data governance strategy within Apellis;
  • Maintain awareness of change request development for the RIMS and EDMS, and ensure appropriate communication and business change management to global users;
  • Monitor the development of new regulatory requirements or guidance and provide advice to Global Regulatory Operations and GRA of the impact on the business;
  • Assist with other activities and projects, as needed.


Education, Registration & Certification:

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

Experience:

  •  8+ years of experience in pharmaceutical/biotech industry, with 4+ years of working experience with Global Regulatory, PV, CMC or Clinical Operations systems.
  • Demonstrated experience developing and managing regulatory tracking databases
  • Strong project management, and timeline management skills; ability to successfully manage multiple complex projects and associated problems and identify and manage risks
  • Strong presentation and communication skills, negotiation and follow-up skills
  • Ability to interact and network effectively with internal customers and external vendors
  • Solid experience in maintenance of GxP, Annex 11 and Part 11 computerized systems
  • Team player with excellent interpersonal skills
  • Ability to influence and manage and communicate with all levels of management in a fast-growing environment
  • Expert knowledge of Microsoft Office, SharePoint, Acrobat, EDMS (Veeva), publishing, validation and viewing tools; expert in use of Excel spreadsheet, Visio, and databases.
  • Expert knowledge of and experience with marketing application procedures globally
  • Solid understanding of EU-PV legislation and adequate experience working with QPPVs
  • Strong knowledge of pharmaceutical standards such as Pharmacopeia, EU controlled terminologies, ATC code, SNOMED, ISO, MedDRA terms, etc.
  • Experience with compliant and timely submission of data to XEVMPD is desirable
  • Profound understanding of product life cycle management, including post-approval commitments and compliance
  • Must be able to assume ownership of the (EU) HA requirements and activities, including XEVMPD, IDMP, Gateways, CESP, etc.
  • Solid experience and familiarity with RIM, EDMS, and e-publishing (eCTD) systems

Skills, Knowledge & Abilities:

  • Extensive knowledge of information tracking systems and submission of data via portals
  • Familiarity with submission dossier concepts, with expert knowledge of global eCTD
  • Demonstrated organizational and project management skills
  • Ability to express oneself clearly and concisely to a variety of audiences
  • Great interest and ability for training
  • Deep understanding of pharmaceutical companies’ operations processes and strategies
  • Ability to lead cross-functional and cross-regional teams and deliver results in a fast-growing organization
  • Strong background in Global Regulatory Affairs as well as understanding of European, US and international regulations in relation 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.