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Regulatory Affairs Specialist

Eingestellt von Next Ventures Ltd

Gesuchte Skills: Support

Projektbeschreibung

Next Ventures is urgently looking for regulatory submissions expert for an exciting position in Bern.

This position is responsible for executing the electronic publishing of regulatory submissions for country specific and regional regulatory agencies and operating companies. As an entry-level position, the primary focus is on regulatory submissions of low-to-moderate complexity both eCTD and non-eCTD format. The range of submission types the incumbent may publish will depend on demonstrated technical skills and competencies and will include, but not limited to, periodic submissions (eg, annual reports, safety updates), CTA, MAA Variation, sNDA/sBLA (low complexity), labeling submissions and response to agency queries. In addition, the incumbent will be responsible for submission support activities including submission QC, component-level publishing per e-submission readiness requirements, and in conformance with the companies standards, templates and practices. The incumbent may also be assigned various publishing tasks associated with complex submissions with appropriate oversight as part of a developmental opportunity.

PRINCIPAL RESPONSIBILITIES:

- Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions.
- QC electronic and paper submissions to ensure compliance with company and agency requirements.
- Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (eg, templates, scanning, indexing)
- Maintain effective interactions with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components taking into consideration special requirements and needs
- Maintain open and timely communication.  
- Participate on special projects and process improvement initiatives  

The incumbent follows established dossier procedures and standards as directed primarily by direct supervisor or dossier leader within the context of the submission plan. The incumbent exercises a limited level of autonomy and judgment on assignments and priority within the context of the submission process. The incumbent generally receives specific task-oriented direction on new or assignments of greater complexity. Priorities are normally designated by supervision.
Independence/Autonomy:
The incumbent will have limited independence and autonomy receiving direction from supervision and site leadership. Work assignments and prioritization of activities will be established by line supervision consistent with business requirements and workload.

REPORTING RELATIONSHIPS:
The incumbent will report to their respective Leader of the Global Dossier Development unit within the organization. From a day-to-day operational perspective, the incumbent may receive supervision and oversight by a  Leader and/or Site Lead depending upon the particular organization site-specific considerations where the incumbent may reside.

EMPLOYEES SUPERVISED: This position does not have direct reports or supervisory responsibilities.

Activities:
- Meet regularly with members of organization to identify and resolve issues and to assess quality
- Interact with the technical managers for RSS submission needs and issues.
- Exceptional interpersonal and teamwork skills are required and must possess strong communication skills.  
- Exercise good judgment and communicates effectively with all levels of the organization.

EXPERIENCE:
Basic understanding of information management concepts and tools needed to support business area.
Use various technical skills to solve publishing/document preparation issues
Can demonstrate a solid command of the technical tools at the level required to perform job duties.

Apply now.

Projektdetails

  • Einsatzort:

    Bern, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    22/12/2013

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Next Ventures Ltd