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Regulatory Affairs Officer - Normal - Belgium   This position is responsible for the management and delivery of regulatory submissions required to support the development, registration, and compliance of products. Depending on the particular project and assigned submission(s)

BrightOwl managed [?] Project on hold
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Functional titles : Industrial Pharmacist ,  Pharmacist ,  Regulatory Affairs Manager
Project Types : Permanent position ,
FTE : 100 %
Min.Experience : 3 year
Start Date : 01 May 2017
End Date : 31 Dec 2017
Posted on : 20 April 2017

Project is currently here

Step 1
Application
Step 2
BrightOwl Screening
Step 3
BrightOwl Interview
Step 4
Company Screening
Step 5
Company Interview
Step 6
Budgets & Contracts
Step 7
Position filled

Project Description

Vacatureplaatsing

This position is responsible for the management and delivery of regulatory submissions required to support the
development, registration, and compliance of products. Depending on the particular project and assigned
submission(s), required activities may include, but not be limited to:
• Establishing Dossier Plans for the assigned submission types / projects considering inputs from functional
area representatives and key stakeholders.
• Maintaining effective interactions with relevant stakeholders and other RSMO colleagues as appropriate to
ensure priority conflicts, resource issues and deviations from the plans are identified and resolved.
• Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating
the electronic component and dossier level publishing and production of regulatory submissions that
conform to regional and country specific regulatory requirements as appropriate.
• Monitoring the effectiveness of appropriate submission processes with responsibility for initiating changes
within the scope of decision-making authority to minimize inefficiencies and ensure quality.
• Meeting regularly with submission stakeholders to identify and resolve issues and to assess quality and
delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.
• Interfacing with cross-functional representatives as appropriate to manage the dossier preparation process
and ensure all aspects of the plan are coordinated and executed efficiently.
• Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating
Companies, as applicable.
• Tracking submission events/activities in appropriate systems/tools.

 

Vacatureplaatsing

 

 

Others

Project FTE 100%
Work from home:   Not Allowed
No. of Positions:   1

Personality

Approachability Attention to detail Communicative Coordination Efficiency Flexibility Organization Problem solving Responsibility Trust

Knowledge

Understanding of regulatory guidelines Regulatory affairs Communication Skills Compliance with regulations

Skills and Expertise

assess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments. Collaborate with project team Communicate effectively on different company levels Communication Generate regulatory submissions Plan work to meet objectives and deadlines Prepare regulatory documents Prepare responses to health authority queries Regulatory submissions Regulatory documentation Solve problems Submit regulatory applications Understand protocols Writing regulatory documents Write documents

Degree

Master

Field of study

Pharmacy (Optional)

Languages

English
Full Proficiency
Mandatory

Desired Skills & Experience

Vacatureplaatsing

Vacatureplaatsing
Principal responsibilities focus on the coordination and/or publishing of product lifespan submissions.
 Associate (Specialist 2) Generally coordinates and compiles, dossier plans and possibly publishes
submission
 Senior Associate (Specialist 3): Ensures compliance with regulatory agency regulations and
interpretations. Coordinates and compiles, dossier plans and possibly publishes submission
 Lead Associate (Specialist 4) – Gathers and assembles and/or publishes information necessary for
submissions in accordance with regulations and relevant guidelines.
 Manager (Manager 1): - Coordinates the preparation and maintenance of regulatory submissions and
filings.
 Associate Director (Manager 2) –. Directs and coordinates activities concerned with the submission and
approval products to government regulatory agencies. Provides guidance to project team members.

These responsibilities, including complexity and scope of submissions, may vary depending on role of employee
and may include but are not limited to the following:
 Manage preparation and/or publishing of submissions across the product lifespan in line with Regulatory
strategy.
 Partner across GRA and functional area contributing groups as needed for assigned projects.
 Establish the Dossier Plan(s) for the lifecycle submissions considering inputs from functional area
representatives and key stakeholders.
 Establish and maintain effective interactions with key partners as appropriate to ensure priority conflicts,
resource issues and deviations from the plan are identified and resolved.
 Ensure that all required documents are included in the dossier.
 Track submission events/activities in appropriate systems/tools.
 Liaise with RSMO staff as required.
 Support development of departmental work practices, process enhancements / improvements, and associated training materials.
 Monitor the effectiveness of the submission process and initiate changes within the scope of decisionmaking
authority to minimize inefficiencies and ensure / improve quality.
 Represent RSMO function on Janssen initiatives where appropriate.
 Develop/maintain associated process tools and relevant training documentation.
 Support compliance needs as appropriate.
May have following publishing activities as defined by the particular role or job function.
 Determine the scope of the electronic publishing requirements for the dossier
 Utilize current electronic document management and publishing technologies to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions with a high degree of independence
 Provide component-level publishing support for Regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.)
 Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements
 QC electronic and paper submissions to ensure compliance with company and applicable health agencyrequirements
 Maintain openly, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission
 Participate on special projects and process improvement initiatives, as needed
 Cultivate ongoing effective relationships with publishing contributors across LSM and RA Therapeutic Areas