In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in Portugal.
You will integrate a team of Regulatory Affairs professionals dedicated to Southern Europe and will have the mission to develop PLG's local Portugal Regulatory Affairs presence, taking responsibility for new regulatory activities related to Portugal for several clients.
Responsibilities Provide guidance and support to continue managing submissions and any other requests from different clients regarding Portugal.
Contribute to the regulatory activities performed. Regulatory activities include pre-licensing activities, new registration (sites and medicinal products), and post-approval applications.
Assist with the preparation of Marketing Authorization Applications (MAAs).
Prepare and submit documentation for post-approval applications including, but not limited to, Type IA, Type IB, Type II, Renewals, MAH Transfers/COAs.
Prepare and submit Technical/Site Transfer Applications.
Assist with license applications as required.
Manage artwork generation/labeling/creation/update of product information: provide review of packaging texts, provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labeling (e.g., QRD compliance check).
Respond to internal requests for technical and/or regulatory information.
Ensure 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 e.g., Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc.
Perform 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.
PT LifeCycle Maintenance (LCM) experience, ideally EU LCM experience as well.
Skills Hard/Technical skills:
Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in PT and ideally EU markets.
Knowledge of PT 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.
Experience in the new registrations of drug products is preferable.
Experience of promotional/non-promotional activities would be an advantage.
Fluency in Portuguese 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-oriented with good attention to detail.
Solution-driven.
About Us ProductLife Group provides world-class regulatory outsourcing and consulting services for the global life sciences industry. Headquartered in Paris, ProductLife Group has offices in countries across Europe, the Middle East, Asia, Africa, Latin America, and North America.
ProductLife Group was founded in 1994 and has since become a global industry leader, thanks to the firm's driven and talented employees, who are always motivated by a supportive team environment as well as opportunities to learn and to grow professionally. Employees and company partners are located in offices worldwide to support clients and drive continued growth.
If you're enthusiastic, if you welcome challenges, and if you want to grow professionally with a management team committed to your development, apply to join us.
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