Senior Regulatory Specialist, Country Labelling
Warszawa lub PoznańSenior Regulatory Specialist, Country Labelling
Warszawa lub Poznań
NR REF.: 1144214
For our client - multinational, innovative company we are looking for a Senior Regulatory Specialist, Country Labelling
You will be responsible for:
Warszawa lub Poznań
NR REF.: 1144214
For our client - multinational, innovative company we are looking for a Senior Regulatory Specialist, Country Labelling
You will be responsible for:
- Authoring and compiling Regional/Country PI as per regulatory authority labelling requirements and company process and standards.
- Authoring and compiling market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and company process and standards.
- Providing support to global and local GRA team members through preparation of other labelling documents as required
- Complete quality and consistency checks of labelling document content.
- Effective coordination and management of labelling documentation and data in regulatory systems.
- Providing advice regarding regulatory authority labelling requirements and labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.
- Effective communication with company staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labelling documents.
- Supporting other regulatory functions and participating in other projects and activities as needed, such as leading the design and implementation of changes to labelling processes and evaluation of new agency labelling requirements.
- Acting as the Subject Matter Expert in country/regional labelling content and process for markets with complex labelling requirements:
- providing coaching, mentoring and knowledge sharing within Labelling skill group
- completing quality checks for colleagues’ outputs
- effective management of interactions with Senior Stakeholders
- taking accountability for the management of labelling deliverables for country/region, including delivery of high-quality outputs to timelines.
- Relevant experience (in pharmaceutical industry, life sciences research or regulatory).
- Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research, pharmacy, safety or regulatory).
- Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple projects for different customers.
- Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
- Broad understanding of the pharmaceutical industry, drug development environment, development and established product lifecycle maintenance and regulatory processes.
- Knowledge and understanding of product labelling (e.g. through direct exposure to the management of labelling documents/submissions/data; including label authoring).
- Experience of maintenance of labelling documents in multiple countries/regions including knowledge of label document content, process and associated regulatory agency labelling requirements. Experience of more than 1 of the following regions/countries: EU PI annexes (including EU CP/MRP/DCP procedures), US PIs, Canadian Monographs, ROW PIs.
- Experience in authoring and/or updating Labelling SOPs, WIs, QRGs by identifying areas for efficiencies in existing Labelling processes.
- Proficient with computer software applications.
- Familiarity with medical terminology required.
- Ability to lead problem solving and negotiate solutions to complex labelling issues.
- Regulatory document management experience (particularly experience of working with and amending Product Information/Labelling Documents).
- Experience and familiarity of working within regulatory systems and communication tools.
- Some experience of managing local and global labelling documents and submissions.
- Experience of communicating with regulatory agencies.
- Experience of EU (including Linguistic review) and US label content and requirements.
- Experience of XML Labelling.
- Proven experience in defining strategy and ensuring delivery of Regional/Country labelling components throughout product lifecycle, product development and launch into markets.
- Experience in supporting regional labelling leads in development/update of labelling content to be applied further to printed packaging components.
- Experience in a variety of Regional Labeling activities with minimal input from function manager.
- Detailed understanding of EU, US and rest of world label content, regulations and requirements.
- Subject matter expert in associated Labelling processes.
- Experience of labelling for pharmaceutical and vaccine products.
- We offer the opportunity to gain experience in well-known company, to cooperate with international environment where you can have an access to cutting-edge technology and work in friendly atmosphere.
- We provide an attractive remuneration package and benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office), as well as the prospects of a comprehensive professional development.
- Access to newest technologies and solutions.
- Possibilities of development within the role and company’s structure.
- Corporate culture based on our values: patient focus, integrity, respect and transparency.
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