Categoria: Regulatory Affairs Manager
Pharmaplanet seeks a Regulatory Affairs & Quality Assurance Manager to integrate a renowned company in the Pharmaceutical Industry in hybrid work.
• To act as Responsible Person as defined in EU GDP Guideline 2013/C 343/01
• To perform Quality Assurance activities on behalf of the affiliate in its capacity as wholesaler and Marketing Authorisation Holder
• Ensure all company products, personnel and third parties conform to local, European and company quality assurance requirements and these requirements are clearly understood by all
• Ensure implementation and maintenance of a Quality Management System, which is compliant with EU GDP Guidelines, local legislation and company corporate quality assurance requirements and is proportionate to the scope of wholesale distribution and marketing authorisation holder activities undertaken by or on behalf of the affiliate
• Maintain independence with regards to QA decision making within the affiliate
• To manage the Quality Assurance team in the affiliate
• To arrange the provision of appropriate regulatory services, compliant with company policies, EU and local laws and guidance, as necessary for the company’s activities in Portugal
• Manage and lead the affiliate RA department and staff with the overall responsibility for all Marketing Authorizations (MA) in scope of the affiliate
• Ensure timely preparation, submission and follow up of new MA applications to the local NCAs and ensures maintenance of authorized products through timely preparation and/or submission of variations, renewals, PSURs or supplements
• Ensure regulatory compliance with company policies, EU and local laws and guidances.
• Liaise within affiliate and with EMEA colleagues on matters relating to MA strategy, life cycle management and compliance
• Collect relevant public available regulatory information and use this information to inform relevant people.
• Develop and maintain professional relationships with relevant external contacts such as governmental bodies and pharmaceutical industry association, where appropriate.
• MS Degree in Pharmacy or other Life Science-related subject
• Minimum 3 years in a comparable role in the pharmaceutical industry
• Proven ability to develop and maintain effective relationship with external bodies
• Quality Assurance experience within the pharmaceutical industry is essential
• Experienced in handling regulatory interfaces such as inspections and audits
• At least 5 years Regulatory Affairs experience, including directly dealing with regulatory agencies
• Knowledge of Regulatory landscape and procedures within the country/region
• Fluency in written and spoken English
• Understanding of EU GDP, EU GMP and Quality Management Systems
• Proven track record of Project Management and good planning skills
• Ability to deliver communication with clarity, impact and tailored to audience
• Proven ability to communicate and influence at most levels of management
• Understanding of local and European regulatory environment
• Ability to interpret and recommend improvements in legal contracts
• Good organizational, coordination, diplomatic, negotiation, presentation and
• Precise, rigorous and reliable with an analytical mind
• Anticipation and rapid decision making skills
Integration in a renowned company in the Pharmaceutical Industry;
Project duration: The duration of this assignement (replacement of worker) is approximately 1 year.
Local: Hybrid work (preferential Lisbon)
Please send your CV through our website Planetmais.pt