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Job Details

Regulatory Submissions Specialist

Company: CTC Resourcing Solutions
Location: Basel, Switzerland
Reference: 895042-P
Closing Date: 10 Dec 16
Type: Contract
Salary (£): On Application
Benefits: Competitive

Job Summary:

For one of our clients, we are currently looking for a Regulatory Submissions Specialist with strong expertise in eCTD submissions. The successful candidate will be responsible for planning, compiling, quality controlling and tracking submissions in Europe, in addition to keeping up to date with changing regulations and provide training to global regulatory professionals.

Requirements:

Reference Number:    895042-P
Type of placement:    Contract, 12 months
Location:                   Switzerland, Basel


Job Responsibilities:

•    Collaborate with DRA project leaders, submission teams, and the DRA Editorial Group on planning, coordinating and tracking eCTD submissions of EU procedures, providing eCTD expertise where required to ensure all submissions are effectively executed 
•    As required, provide support to the Regional Management Group far eCTD/NeeS submissions
•    Publish documents for electronic submissions in eCID format using appropriate tools
•    Check electronic documents, and reformat to standards as required, to ensure eCTD compliance
•    Be responsible for submission compilation: assigning metadata, locations within the eCTD modular structure (with guidance from document authors where necessary), building XML backbone, eCTD leaf titles, lifecycle operators in accordance with company procedures and standards. Where required by DRA management, liaise with a submissions outsourcing partner on these activities
•    Be responsible for quality control of the submission, its contents and backbone, both manually and through appropriate validation software applications
•    Managing the submission of eCTD dossiers through the relevant gateway/portal (e.g. EMA Submissions Gateway, Central European Submission Portal (CESP))
•    Monitor changing eCTD regulatory submissions environment and procedures, and implement new eCTD guidance as required
•    Act as the Data Entry Responsible for the Regulatory Management System (RMS) in line with the relevant quality system documents
•    Evaluate vendors for appropriate systems/tools to support establishment of new technical capabilities related to the work of Regulatory Operations
•    Assist with software validation, testing of new releases and new applications, and system implementation
•    Act as System Manager and/or Business Administrator for systems under the responsibility of Regulatory Operations
•    Provide appropriate training to global regulatory professionals on eCTD publishing processes and technology requirements in the preparation, publishing and life-cycle management of electronic submissions
•    Provide iTRACK user support for members of Clinical Development, who contribute documents for submission to competent authorities, including training or refresher training for users
•    Provide input to quality system documents related to the work of Regulatory Operations

Qualifications and Experience:

•    A minimum of two years of experience in making electronic submissions in eCTD format
•    Fundamental understanding of eCTD regulatory guidance in the EU
•    Excellent Acrobat skills and experience in electronic publishing of documents
•    Committed attention to detail: accurate and meticulous
•    Proven ability to work independently and under pressure (able to prioritize tasks! deadline-oriented, good organizational skills) and as a team member
•    Ability to problem solve complex problems (strong analytical skills)
•    Self-motivated, with initiative and ability to work in a fast-paced! high-volume environment
•    Ability to communicate effectively in English (spoken and written)
•    Experience of working effectively in a cross-cultural environment and matrix environment  preferred
•    Customer-oriented attitude 
•    Fundamental understanding of eCTD regulatory guidance with regard to EU, US and ASEAN submissions  would be an advantage
•    Previous experience with electronic document management systems, building eCTD submissions  and  using a Regulatory Information Management System (RIMS) would be an advantage
•    Knowledge of eCTD publishing software, XML and ISIToolbox would be an advantage
•    Experience with training would be an advantage
•    Understanding of eCTD regulatory guidance in countries outside of EU & US (e.g. Saudi Arabia, Thailand, etc.) would be an advantage

Apply for this job: Regulatory Submissions Specialist

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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