Job Reference: 24629
Job Duration: 6-12 months
Start date: ASAP
Description:
My client, a large pharmaceutical company in the Uxbridge area, is looking for a Senior Associate GRAAS Regulatory Operations on a contract basis.
Description
* Provide regional expertise on requirements for electronic document management, submission planning and content, publishing standards, and filing strategy.
* Manage regional submissions as a lead publisher and support global submissions.
* Proactively communicate requirementsand issues to be considered to the Submission Team, and contribute to achieving timelines.
* Proactively collect necessary information from the Submission Team, and plan all submission management related activities.
* Proactively communicate with cross-functional colleagues on submission requirements including eCTD
* Liaise with global regulatory affairs staff regarding technical/format requirements on submission deliverables.
* Perform quality checking of documents and regulatory submissions to ensurecompliance with Amgen style and submission-ready standards.
* Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools.
* Ensure printing and distribution of regulatory submissions, paper andelectronic, as required.
Qualifications
* Bachelor's degree or relevant equivalent experience
* Three years pharmaceutical experience in a regulatory environment.
* Two to four years' experience with information management, document management technology, and electronic publishing software (Insight Publisher preferred).
* Expertise in drug development, including knowledgeof the contents/ formatting of regulatory submissions and product life-cycle and how other functions contribute to regulatory submissions
* Knowledge of regulatory authorities requirements on electronic submissions in several regions (e.g., Canada, US, EU, MEA, etc.)
Experience:
* Specialist knowledge of pharmaceutical/biotech industry gained in operationally focused role
*Working in partnership with publishing vendors
* Dossier and Submission related Regulatory Guidance for EU, CAN, MENA and theEmerging Markets
* Successful submission and maintenance of marketing applications in multiple regions
If the above is of interest and you feel you have a suitable profile, please apply and get in touch with Ross Wilson at rwilson@keypeople.co.uk forfurther information.
Industry: Pharmaceuticals
Salary: £25 - £35.00 per hour
Salary Benefits:
Vacancy Type: Permanent
Job Skills: Regulatory Operations, Publishing, eCTD, Pharmaceutical
Contact Name: Ross Wilson
Website: -
Direct Application URL: -