Manager - Regulatory 181

Groupe ProductLife; Alicante; Presencial; EUR 45.000 - 70.000; Jornada completa

Descripción de la vacante

A growing company seeks a Regulatory Affairs Specialist to enhance their team in Spain. The role involves developing regulatory activities, managing submissions, and ensuring compliance with guidelines. Ideal candidates will have a Bachelor’s in Life Sciences, 5+ years of experience in regulatory affairs, and strong organizational skills.

Formación

• At least 5 years of experience in Regulatory Affairs in a Pharmaceutical Company.
• ES Lifecycle Maintenance experience, preferably with new registrations.
• Ability to prioritize workloads and coordinate within a team.

Responsabilidades

• Manage regulatory submissions and requests for various clients.
• Prepare and submit documentation for Marketing Authorization Applications.
• Ensure compliance with national and European guidelines and legislation.

Conocimientos

Organizational skills

Interpersonal skills

Coordination skills

Attention to detail

Educación

Bachelor’s Degree in Life Sciences

Pharmacy Degree

Herramientas

Microsoft Office Suite

Veeva Vault

LorenZ

Trackwise

PromoMat

Descripción del empleo

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 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 5 years of experience in RA in a Pharmaceutical Company or Service Provider
• ES LifeCycle Maintenance (LCM) experience, Category 1 Drugs
• Experience in the new registrations of drug products is preferable.

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

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