Drug Regulatory Affairs Coordinator (50%)

Harvey Nash is looking for a Drug Regulatory Affairs Coordinator for a 6 month project with 50% workload in Switzerland. A daily presence is mandatory.

The Regulatory Coordinator is responsible for providing operational regulatory and compliance support to the global program team representative and/or GTAL on development projects/major line extensions through development, registration, and approval including post approval commitments. Please be aware, that this role is mostly an administrational and coordinator role. RA experience is not necessarily a must.

You are responsible for

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

* Providing support as needed for non-project related regional excellence activities.

* Preparing changes to Safety Labelling triggered by PSB or GLC.

* Preparing 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

* Managing and executing drug shipping ticket review process (US).

* Coordinating the development of Module #1 in the CTD.

* Coordinating compilation and review of Briefing Books for regulatory Health Authority meetings.

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

* Assisting 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.

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

* Tracking response to Health Authority Queries.

Requirements

* Must be experienced administrator or Co-ordinator

* Good computer skills with word/ppt/excel

* Good communicator

* Reliable & well organised

* 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 within Development or Regulatory Affairs

* 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.

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.