• Regulatory Affairs Officer II Jobs in Poland - 25701288

  • Iqvia
  • Poland

Job Description:

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward

RESPONSIBILITIES

Acts as a Regulatory Team member involved in projects, under the guidance of senior staff
Manages day-to-day workload in collaboration with senior staff, as appropriate
Prepares and/or reviews regulatory documentation in area of expertise, as appropriate
Actively participates with internal and external customers and communicates confidently in straightforward matters
Understands the Scope of Work, and deliverables for a given project
May prepare slides and background material for meetings under senior guidance and present to clients by phone or in person
Preparation of submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, CMC authoring and or updates as required

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Technical Skills/Experience

4-5 years regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (eg variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)

Preparation of relevant CTD (Common Technical Dossier) documents to support submissions (mainly Module 1), in collaboration with Technical/CMC/Labelling experts
Quality review of technical/ regulatory documents
Interaction with Regulatory Agencies (EU and/or National Agency)

Regulatory strategy and determination of documentation requirements, timelines, budgets
Revision/review of regulatory SOPs, as appropriate
Project management experience - an advantage
Broad experience in preparing international dossiers including APAC regulatory requirements

Soft Skills

Ability to work to tight timelines and manage peaks in workload
Good team player
Good negotiating skills and the ability to identify and resolve issues
Excellent verbal and written communication skills
Excellent computer skills eg Word, Excel, data and document management systems
Cultural awareness for global ways of working
Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate

Key words phrases are

Post Approval; Variation; Renewal; Referral; change control assessment; regulatory strategy; team work

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience*

(*or combination of education, training and experience)

5 years regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (eg variations, renewals, new Marketing Authorisation Applications (MAAs) submissions

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage It takes brave minds, pushing the boundaries to transform healthcare Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients

Forge a career with greater purpose, make an impact, and never stop learning

Job ID R1062340

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : IT Software : Software Products & Services
Role : Software Engineer
Salary : As per Industry Standards
Deadline : 19th Jul 2020

Key Skills:

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