Regualtory Affairs - Operations in Maryland Heights, MO at Apex Life Sciences

Date Posted: 8/10/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/10/2018
  • Job ID:
    876259

Job Description


Apex Life Sciences is looking for a Regulatory Affairs Associate! 

This position will handle all responsibilities of administrative assistant supporting Regulatory Affairs - Operations.  The site is a 24/7 operation that has approximately 300 employees.  This role will be positioned in our leadership building with other senior leaders, project management, R&D, Regulatory Affairs, Procurement and some of our Quality groups.  The Regulatory Affairs Associate will provide high-level support and coordination handling daily administrative duties in a professional manner while maintaining confidentiality.

Essential Functions:

The Regulatory Affairs Associate role is responsible for a broad array of Regulatory Affairs activities including leadership support, team support, site support, and other general administrative items.

Most areas of focus will be in:

  • Signature Support –Coordinate documents for signature and process to appropriate parties.
  • Presentation, Communication and Reporting Development –Prepare presentations, charts, graphs, reports, spreadsheets.  Create written communications such as letters, memos, meeting minutes, e -mails, etc. Compile documents and update SharePoint sites for meetings, metrics, etc. Semi-autonomously compiles/assembles, maintains and updates required files and all associated documents, to comply in a Regulatory environment.
  • Meeting Planning & Coordination –Schedule and arrange plant-wide meetings, plant tours and other special events.  Participate in meetings for the CARE(culture, activity, recognition, events)committee and provide administrative support for the team for events and meetings as needed.
  • Calendar Management –Support team and site by managing tasks, deadlines, calendar invites, inquiries from others regarding leader availability, etc.
  • Attention to Detail and File Management–Prints and verifies accuracy of printed information that will be issued to manufacturing for labeling and packaging operations.  Prints test labels for manufacturing and validation purposes.  Shares rotational on-call duties to issue labels during off-shift hours.
  • Reviews documents and artwork to ensure completeness, accuracy, and compliance.
  • Management of the records information life cycle which includes collection (collect and retrieve), maintenance(use, file and access) and disposition (destruction and transfer).
  • Ability to prepare, maintain and organize documents, records, etc.
  • Compliance – Follows all applicable procedures and assures alignment with regulation requirements.
  •  Complies with internal and external regulations regarding the maintenance, labeling, and organization of electronic and paper documents.
  • Promote a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP’s etc.
  • Multitasking – Assist in labeling changes with Regulatory Affairs and other departments.
  • Assist with creation of weekly printing schedule, communication with other departments.
  •  May create and document processes, create and send communications, and manage other projects as needed.
  • Additional support to be determined as needed.

Requirements:

  • Associate’s degree required, Bachelor level degree preferred with applicable work experience.
  • Minimum of 1-3 years of experience as an administrative assistant or coordinator in a regulatory affairs environment with demonstrated experience multitasking, or work experience in a related environment.
  • Experience with computer data entry required, maintenance, conversion.
  • Label or process experience in a cGMP facility is a plus.  General GMP/Quality experience will also be considered.
  • Basic familiarity of FDA regulations, global regulatory guidance and CFR Title 21 considered to be a plus. Desire to grow into a subject matter expert and willingness to expand regulatory intelligence is essential.
  •  Must be proficient with Microsoft Office, including Word, Excel, Access, Outlook, and Power Point with some SharePoint familiarity. Willingness to use technical savvy to expand technical skill set to encompass learning curves of various new software programs.
  •  Experience concurrently organizing, coordinating, arranging, scheduling, pulling together current metrics for frequently changing projects etc. a plus.
  • Create tracking reports and provide forward-looking schedule analysis for various levels of management
  • Strong capability in organizing ideas, documents and processes
  •  Experience dealing with multiple requests with ability to stay focused, prioritize and consistently re calibrate workload to meet and potentially exceed expectations.
  • Ability to closely adhere to all instructions, cGMP's, SOP's, policies and procedures.
  •  Ability to handle ambiguous environment with changing needs and multiple demands.
  • Remains professional and patient in working through issues.
  •  Resourceful at gathering information and putting ideas together to execute against requests.
  • Strong organizer of information: including both electronic and physical items in store room, files, etc. as well as electronic documents. Capable of managing this information throughout its life cycle — regardless of source or format (data, paper documents, electronic documents, audio, video, etc.).
  • Significant written and oral communication capabilities; demonstrated ability to communicate broadly with internal and external stakeholders.
  • High degree of personal integrity, discretion and diplomacy.
  • Strong collaboration skills working individually and as a team.
  • Willing to work occasional overtime and weekends as the business need dictates.
  • Perform other regulatory affairs functions as necessary.

EEO Employer

Apex 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. 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 employeeservices@apexsystemsinc.com or 844-463-6178.