Regulatory Affairs Officer

Région
Beerse
Publication
vendredi 14 avril 2017
Date limite
dimanche 14 mai 2017
Réf
72AAEXPE-BE
Contact
Andreea Ardelean
Fonction
Autre
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Regulatory Affairs Officer Organisation description:

XPE Pharma & Science is looking for a Regulatory Affairs Officer, for one of its clients, a well-known company in international environment. University/Bachelor's degree or equivalent experience required, combined with 2-4 years of experience in the pharmaceutical industry or related experience.

Job description:

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.

PRINCIPAL RESPONSIBILITIES: 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 decision making authority to minimize inefficiencies and ensure / improve quality;  Represent RSMO function on company 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 agency requirements;  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. Leadership Competencies: LIVE OUR CREDO lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people. CONNECT - works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mind set; champions best practices. SHAPE - able to persuade, convince, or influence others, in order to gain support for an idea or a course of action he or she wants others to adopt. LEAD - assumes personal ownership and accountability for business results and solutions; consistently delivers results that meet or exceed expectations; makes the customer central to all thinking; keeps the focus on driving customer value. DELIVER - proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed.

Profile:

 Regulatory Affairs competencies and proficiency levels vary based on role and may include: Applied Technical Knowledge, Business Acumen, Decision Making and Prioritization, External Focus, Leading and Influencing, and Persuasive Communication;  Therapeutic area and product knowledge, understanding of drug development process preferred;  Demonstrated project or submission management capabilities preferred;  Demonstrations of effective interpersonal, teamwork, and communication skills required;  Exercises solid judgment and communicates effectively with varied levels of the organization;  Demonstrated ability to work or lead in a matrix environment;  Ability to build productive relationships across the organization;  Proficiency in submission related HA and Industry regulations and guidelines as relevant for particular role;  Problem solving capability required, trouble shooting and adaptability;  Regulatory Information systems, planning and publishing tools as required for particular role. DECISION-MAKING AND PROBLEM-SOLVING:  Follow established dossier procedures and standards on assignments and priorities within the context of the submission process. Regulatory Associates, Senior Associates, and Lead Associate will work to resolve issues for assigned products/projects with varying degrees of direct supervision related to their level. Managers and Associate Directors will make decisions and resolve issues with limited supervision. Independence/Autonomy  This role works under the supervision of the RSMO TA Head/COP or RSMO Publishing Head/COP. Regulatory Assistants, Associates and Senior Associates, and Lead Associate will manage/lead with varying degrees of direct supervision related to their level. Managers and Associate Directors will manage/lead with limited supervision.  University/Bachelor's degree or equivalent experience required and generally requires 2-4 years of experience required in the pharmaceutical industry or related experience.

Offer:
  • Open end contract on XPE payroll;
  • Highly professional working environment & opportunity to have a good start into your career


Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713