In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in Spain.
You will integrate a team of Regulatory Affairs professionals dedicated to Southern Europe and will have the mission to develop PLG's local Spain Regulatory Affairs presence, taking responsibility for new regulatory activities related to Spain for several clients.
Provide guidance and support to continue managing submissions and any other requests from different clients regarding Spain.
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
Education At least a Bachelor's Degree in Life Sciences, ideally a Pharmacy Degree
Experience At least 3 years of experience in RA in a Pharmaceutical Company or Service Provider
ES LifeCycle Maintenance (LCM) experience, ideally EU LCM experience as well
Experience in the new registrations of drug products is preferable.
Experience of promotional/non-promotional activities would be an advantage (3 to 5 years ideally)
Skills Hard/Technical skills:
Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in Spain and ideally EU markets.
Knowledge of ES regulation for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products and Cosmetics
Strong computer skills, including MS Office applications, data and document management systems
Experience in project management
Fluency in Spanish and English
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
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