Manager - Regulatory 181

Groupe ProductLife; Murcia; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector is seeking a Regulatory Affairs Specialist to enhance its regulatory presence in Spain. The role involves managing submissions, preparing marketing authorization applications, and ensuring compliance with regulatory processes. Ideal candidates will have a Bachelor’s Degree in Life Sciences, at least 5 years of experience, and strong organizational skills.

Formación

• At least 5 years of experience in Regulatory Affairs.
• Experience with ES LifeCycle Maintenance (LCM) and new registrations.
• Ability to work autonomously and in a team.

Responsabilidades

• Manage submissions and requests for regulatory activities in Spain.
• Prepare and submit Marketing Authorization Applications (MAAs).
• Ensure compliance with regulatory processes and maintain knowledge of guidelines.

Conocimientos

Organizational skills

Interpersonal skills

Coordination skills

Attention to detail

Ability to prioritize

Educación

Bachelor’s Degree in Life Sciences

Pharmacy Degree

Herramientas

Microsoft Office Suite

Veeva Vault

Trackwise

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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