Regulatory Affairs Associate (Submission Planning)

Regulatory Affairs Associate (Einreichungsplanung)

Location

Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

  • Prepares submission-specific ‘envelope’ documents with appropriate support. 
  • Prepares virtual documents within the regulatory electronic document management system, where appropriate.
  • Creates and imports documents into the regulatory electronic document management system on behalf of the functional teams to aid the content authors.
  • Communicate with the appropriate Operations team members to ensure ongoing regulatory activities and registered details are captured within the Regulatory Affairs tracking database.
  • Ensures that documents required for submission to regulatory authorities are properly formatted, reviewed/ approved, tracked and retrieved according to regulatory guidelines and internal business procedures.
  • Supports Independent Associated Companies (IAC’s) and the company on maintenance of the product ‘envelopes’ within the regulatory electronic document management system.
  • Raise issues related to area of expertise with the line manager and/or appropriate Regulatory Affairs Sub-Team (RAST) members and perform actions to address these issues, as agreed.
  • Ensures, where appropriate, that the regulatory document management system is used for all submission documents.
  • Works as a team player and perform all reasonable tasks related to regulatory activities in accordance with the priority settings.
  • Ensures that the appropriate departmental procedures and standards of good regulatory practice are employed. 
  • Develops and document new working practices as appropriate.
  • Attends and participate in appropriate learning events for both personal and professional development.
  • Undertakes any other reasonable tasks as required.

Key Competencies

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Main requirements

Qualifications & Experience

  • Has conceptual knowledge of theories, practices and procedures within a discipline typically acquired through a college or university degree or the equivalent work experience.
  • Typically uses existing procedures to solve routine or standard problems. Use of Word, Excel and PowerPoint and flexibility to learn new IT systems e.g.
  • electronic databases and document management systems.
  • Have strong administration and organisation skills.
  • Awareness of technical and scientific information, legislation and relevant regulatory guidelines.
  • Possesses good written and oral communication skills.

Personal & Leadership Characteristics
  • Taking personal responsibility, ownership and accountability for decision marking, problem solving and managing regulatory projects.
  • Working to strict deadlines and managing own time.
  • Building effective working relations internally and externally.
  • Completes work with a limited degree of supervision.
  • Actively working as a team member and contributing to the success of the team.
  • Positive work style, with an approachable, flexible manner.
  • Has a high attention to accuracy and detail.
  • Consistently demonstrates and encourages others to demonstrate the Company’s Core Values; Honesty, Respect, Passion, Innovation, and Commitment.
  • Strong ethical standards and a high level of personal integrity.
  • Adheres to the Company’s Compliance and Code of Business Ethics guidelines.

Contact Information

Name: Sophie Anthony
Email: MR.HR@mundipharma-rd.eu
Telephone: 01223 400400
Adress: Mundipharma Research Limited
Unit 196
Cambridge Science Park
Milton Road
CB4 0GW

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