Regulatory Affairs Specialist M/F - 178

In the context of our growing activities, we are looking for a Regulatory Affairs Specialist M/F to join our teams in Poland.

You will integrate a team of Regulatory Affairs professionals dedicated to Central Europe and will have the mission to develop PLG’s local Poland Regulatory Affairs presence, taking responsibility for new regulatory activities related to Poland for several clients.

• Provide guidance and support to continue managing submissions and any other requests from different clients regarding Poland.
• Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products) and post-approval applications.
• Assisting with the preparation of Marketing Authorization Applications (MAAs).
• Preparation and submission of documentation for post-approval applications including, but not limited to, Type IA, Type IB, Type II, Renewals, MAH Transfers/COAs
• Preparation and submission of Technical/Site Transfer Applications
• Assisting with license applications as required
• Management of artwork generation/ labelling/creation/update of product information: provide review of packaging texts, provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
• Responding to internal requests for technical and/or regulatory information.
• Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
• Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
• Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc
• General regulatory administration duties and compliance requirements
• Document and track regulatory submissions and regulatory authority approval.
• Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services

• At least a Bachelor’s Degree in Life Sciences, ideally a Pharmacy Degree

• At least 3 years of experience in RA in a Pharmaceutical Company or Service Provider
• PL LifeCycle Maintenance (LCM) experience, ideally EU LCM experience as well

Hard/Technical skills:

• Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in PL and ideally the EU
• Knowledge of PL regulation for pharmaceuticals (NCE, Biologicals and Biotech) and ideally for Medical Devices, Combination products and Cosmetics
• Strong computer skills, including MS Office applications, data and document management systems
• Experience in project management
• Experience in the new registrations of drug products is preferable.
• Experience of promotional/non-promotional activities would be an advantage
• Fluency in Polish and English

Soft skills:

• Excellent communication skills
• Excellent organizational and interpersonal skills
• Very good coordination skills
• A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
• Ability to work well within a team and autonomously
• Ability to prioritize different workloads/multi-task
• Process orientated with good attention to detail
• Solution-driven