Regulatory Operations Associate

Search Consultancy


Job ID :

9681


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--Cambridge,Cambridge,


Key Skills :

Regulatory


Salary :

Negotiable


Date Posted :

04 Dec, 2017



Company Name :

Search Consultancy


Location1 :

Cambridge




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Regulatory Operations Associate
Cambridge
12 month temporary role
£18.75 per hour

Summary of Responsibilities:

As a member of the Regulatory Information Systems team (RIS), contribute to the support, and administration of the Regulatory Affairs software platforms, applications, and tools. Provide expertise in electronic information management and submission tools and strategies to assist other members of Regulatory Affairs and Regulatory Operations during submission preparation and delivery. Participate in Tier 1 and support Tier 2 system activities. Work across functional areas, primarily with IT counterparts, to ensure the needs of the Regulatory Affairs department are met. Work across geographic regions to provide support in conjunction with other members of RIS. May serve as a resource within the team on system validation testing development and execution deliverables.

The duties of the role include:

* Act as first line support for the publishing tool, Lorenz Docubridge and document management system, FirstDoc.
* May identify basic issues and proactively engage senior associates for resolution
* Maintains and responds to user issues reported through the IT ticket tracking system.
* Serves as a system Business Administrator (privileged user), assists with submission development and maintenance, as needed.
* Supports and delivers any systems training as needed
* Provisioning of new systems accounts and changes through the Identity Management System.
* Assist the group with system administrative support matters concerning documentation and archiving
* Participates on platform Core Teams
* Troubleshoots existing practices and tools to solve day to day problems as they arise.
* Works closely with the training team within RIS to provide analysis and documentation support for training, as needed.
* Remains knowledgeable of industry trends, changes to regulations and guidances as they pertain to submission activities.
* Maintains a proficiency and expertise with the tools and processes associated with regulatory submissions.
* Participates in both group and cross-functional process improvement and development initiatives

Qualifications

Regulatory Systems and/or Operations experience preferred, optimally within both a start-up/small biotech company and a large pharmaceutical/healthcare company, with direct experience in system implementation and support.

-Familiarity with global Regulatory submissions and document management a plus.
-Strong computer skill set and working knowledge of electronic submission requirements.
- A basic knowledge of computer system validation a plus.
- Must be able to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy customers.
- Must be able to work effectively within an environment that has quickly changing processes, priorities, and deadlines.
-Experience working with cross-functional teams a plus.
-Strong verbal and written communication skills and the ability to describe and present information.
- Must be able to master new software and technical skills and apply them to projects as the industry, and the company evolves.
- Familiarity with pharmaceutical development and Regulatory global submissions is a plus.

Requires a BA or BS degree in a scientific discipline or equivalent, with relevant experience from the pharmaceutical or biotechnology industries.

If you are experienced in Regulatory systems and are looking for a new challenge then please apply now!

Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age


Company Name:

Search Consultancy


Headquarters:

Campbell House,215 West Campbell Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

G24TT


Website:

www.search.co.uk


Employees:

100 - 499


Industry:

Pharmaceutical


City:

Glasgow


Phone No. :

01618358600


For more information,visit www.search.co.uk.

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