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Drug Regulatory Affairs Coordinator (50%)

Eingestellt von Harvey Nash IT Recruitment Switzerland

Gesuchte Skills: Support, Client


For our client in Basel we are looking for a Drug Regulatory Affairs Coordinator for a 6-month contract.

Duration: ASAP-15.04.2018

Workload: 50%

Place: Basel

Drug Regulatory Affairs Coordinator 50% (daily presence mandatory)

* Must be experienced administrator or Co-ordinator

* Good computer skills with word/ppt/excel. Able to co-ordinate multiple tasks

* Gets on well with others - Able to work closely with current person in role (who is on reduced work time)

* Preferable experience in pharma industry - If possible within Development or Regulatory Affairs

Job Purpose:

The Regulatory Coordinator is responsible for providing operational regulatory and compliance support to the DRA global program team representative and/or GTAL on development projects/major line extensions through development, registration, and approval including post approval commitments.

Major Accountabilities:

§ Support regulatory compliance activities, including entering product specific attributes as provided by program team representative into compliance database.

§ Provide support as needed for non-project related regional excellence activities.

§ Prepare changes to Safety Labelling triggered by PSB or GLC.

§ Prepare Routine Health Authority submissions including Annual Reports, New Protocol Submissions, Protocol Amendment Submissions, etc. and act as main liaison with DRA Operations to ensure accurate and timely submissions to HAs

§ Manage and execute drug shipping ticket review process (US).

§ Coordinate the development of Module #1 in the CTD.

§ Coordinate compilation and review of Briefing Books for regulatory Health Authority meetings.

§ Facilitate the timely delivery of sections to compile the IND/IMPD (CTAs) and NDA/MAA/CTD for Health Authority submissions.

§ Assist in the preparation of regulatory deliverables (ie power-point presentations, excel spreadsheets, informal tracking for deliverables).

§ Additional support for team communications on planning and logistics for Health Authority Meetings.

§ Provide operational support for obtaining up-to-date Regulatory Intelligence and other regulatory support Information Review and approval of Clinical Supplies/Labels (US).

§ Track response to Health Authority Queries. KPIs

§ Timely delivery of Safety Labelling change submissions.

§ Timely delivery of Routine Health Authority submissions.

§ Timely completion of Drug Shipping Process (US).

§ Timely completion of Module #1 in the CTD.

§ Timely completion of briefing books for regulatory Health Authority meetings.

§ Timely delivery of IND/IMPD and NDA/MAA/CTD to Health Authorities.

§ Regulatory deliverables met (ie power-point presentations, excel spreadsheets, informal tracking for deliverables).

§ Timely delivery of Regulatory Intelligence and other regulatory support information

§ Timely approval of Clinical Supplies/Labels.

§ Completion of submissions to Health Authority Queries.

Languages: Fluency in English as a business language


Ideally 1-2 years pharmaceutical experience and/or 1-2 years of regulatory experience.
Prior publishing/Regulatory Operations experience desired.
Good communication and negotiation skills.
Proactive personality.
Fast and flexible, focused on timely delivery and stretch targets
Ability to plan and prioritise workload
Ability to work in a matrixed environment.
Ability to build effective relationships across teams/projects.

For more information, please contact:

Anna Chmura (see below)


  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:


  • Projektdauer:

    6 months

  • Vertragsart:


  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Switzerland