Regulatory Affairs Manager

hace 1 mes

Barcelona, España Innovaderm Research A tiempo completo

.The Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm's standard operating procedures, applicable regulations and good clinical practices and to the Sponsor's satisfaction.Responsibilities include:Providing leadership on regulatory activities that lead to global startup of clinical trials.Planning and assigning work, overseeing the performance of direct reports, and performing annual reviews.Addressing employee relation issues, and escalating issues.We are looking for someone who has:Experience as a lead and escalation point of contact for global projects.At least 5 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry.Experience with oversight of preparing and submitting part I and/or part II Clinical trial applications following EU CTR.More specifically, the Senior Manager, Regulatory Affairs must:Manage a team of Regulatory Affairs employees, conduct formal performance reviews, and participate in talent conversation meetings.Ensure adequate resources (i.E., headcount, experience, training) to sustain regional activities of the regulatory affairs group.Manage resource selection and onboarding processes for new employees.Ensure adequate training of the regulatory affairs group and oversee regulatory affairs practices to ensure alignment of practices across the team through adoption and use of all process and technology tools.Ensure the regulatory affairs' activities are delivered on time, within budget, and in compliance with SOPs and regulations.Identify and report out of scope activities to the project team.Develop regulatory affairs practices, improvement initiatives, tools, processes, and training material to support departmental activities.Provide regulatory submissions strategic advice and may act as point of contact for Sponsors and subcontractors/project teams.Oversee resource assignments and participate in the preparation, review, submission, maintenance, and tracking of regulatory authority and IRB/IEC submissions.Ensure adequate review of activities performed outside of the company by subcontractors (e.G., partner CROs, vendors, consultants) to ensure high quality standards before submission.Support project teams with oversight of submissions in global regions, such as Asia Pacific.Prepare and/or review master and country-specific Informed Consent form documents.Assist with the oversight of vendors supporting the department (e.G., central IRB, translation).Oversee regulatory review of essential documents to authorize shipment of investigational product to clinical sites.Oversee labeling review of clinical trial drug supplies to ensure conformity with regional regulations requirements.Oversee the activities associated with clinical SAE reporting (tracking and submission to regulatory authorities, IRB/IEC, and Investigators)

  • Regulatory Affairs Manager

    hace 4 semanas

    Barcelona, España Meet Recruitment Limited A tiempo completo

    .Global Regulatory Affairs ManagerWe're currently seeking a Global Reg Affairs Manager for an award-winning pharma company specialising in OTC products. Overseeing the whole dossier process, working with license variations, acting as a submission specialist will all be core components of this role!The Regulatory Affairs Manager will be responsible for...

  • (Hfe133) Regulatory Affairs Manager

    hace 2 semanas

    Barcelona, España Meet Recruitment A tiempo completo

    Global Regulatory Affairs Manager We're currently seeking a Global Regulatory Affairs Manager for an award-winning pharma company specialising in OTC products.Overseeing the whole dossier process, working with license variations, acting as a submission specialist will all be core components of this role!The Regulatory Affairs Manager will be responsible for...

  • (Hfe133) Regulatory Affairs Manager

    hace 2 semanas

    Barcelona, España Meet Recruitment A tiempo completo

    Global Regulatory Affairs ManagerWe're currently seeking a Global Regulatory Affairs Manager for an award-winning pharma company specialising in OTC products. Overseeing the whole dossier process, working with license variations, acting as a submission specialist will all be core components of this role!The Regulatory Affairs Manager will be responsible for...

  • Regulatory Affairs Manager

    hace 5 días

    Barcelona, España Es16 Alcon Healthcare S.A. Company A tiempo completo

    At Alcon, we are driven by the meaningful work we do to help people see brilliantly.We innovate boldly, champion progress, and act with speed as the global leader in eye care.Here, you'll be recognized for your commitment and contributions and see your career like never before.Together, we go above and beyond to make an impact in the lives of our patients...

  • Regulatory Affairs Manager

    hace 7 días

    Barcelona, España Mcr International A tiempo completo

    LAR-2409-288 REGULATORY AFFAIRS MANAGER MADRID From MCR International , we are looking for a Regulatory Affairs Manager with a proven track record in the agrochemicals industry .If you are looking to join a fast-growing company with a strong vision and a collaborative culture, this is your opportunity.This role could be based in Spain, ideally located in...

  • Regulatory Affairs Manager

    hace 4 semanas

    Barcelona, España Meet A tiempo completo

    Global Regulatory Affairs Manager We're currently seeking a Global Reg Affairs Manager for an award-winning pharma company specialising in OTC products.Overseeing the whole dossier process, working with license variations, acting as a submission specialist will all be core components of this role!The Regulatory Affairs Manager will be responsible for...

  • Regulatory Affairs Director

    hace 4 días

    Barcelona, Barcelona, España Meet Recruitment A tiempo completo

    Global Regulatory Affairs ManagerWe're seeking a highly skilled Global Regulatory Affairs Manager to oversee the regulatory process for our OTC products.Key Responsibilities:Oversee the dossier process and manage license variationsAct as a submission specialist and ensure compliance with applicable regulations and standardsLead the regulatory process from...

  • Regulatory Affairs Director

    hace 4 días

    Barcelona, Barcelona, España Meet Recruitment A tiempo completo

    Global Regulatory Affairs ManagerWe're seeking a highly skilled Global Regulatory Affairs Manager to oversee the regulatory process for our OTC products.Key Responsibilities:Oversee the dossier process and manage license variationsAct as a submission specialist and ensure compliance with applicable regulations and standardsLead the regulatory process from...

  • Regulatory Affairs Manager

    hace 4 semanas

    Barcelona, España Meet A tiempo completo

    Global Regulatory Affairs ManagerWe're currently seeking a Global Reg Affairs Manager for an award-winning pharma company specialising in OTC products.Overseeing the whole dossier process, working with license variations, acting as a submission specialist will all be core components of this role!The Regulatory Affairs Manager will be responsible for...

  • Regulatory Affairs Manager

    hace 4 semanas

    Barcelona, España Meet A tiempo completo

    Global Regulatory Affairs ManagerWe're currently seeking a Global Reg Affairs Manager for an award-winning pharma company specialising in OTC products. Overseeing the whole dossier process, working with license variations, acting as a submission specialist will all be core components of this role!The Regulatory Affairs Manager will be responsible for...

  • Regulatory Affairs Manager

    hace 3 días

    Barcelona, España Mcr International A tiempo completo

    LAR-2409-288REGULATORY AFFAIRS MANAGERMADRID From MCR International, we are looking for a Regulatory Affairs Manager with a proven track record in the agrochemicals industry.If you are looking to join a fast-growing company with a strong vision and a collaborative culture, this is your opportunity.This role could be based in Spain, ideally located in...

  • Regulatory Affairs Manager

    hace 1 mes

    Barcelona, España Innovaderm Research A tiempo completo

    .The Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm's standard operating procedures, applicable regulations and good clinical practices and to the Sponsor's satisfaction. Responsibilities include providing leadership on regulatory activities that...

  • Regulatory Affairs Specialist

    hace 5 días

    Barcelona, Barcelona, España The Health Club A tiempo completo

    Regulatory Affairs ManagerThe Health Club is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for ensuring the regulatory compliance of our OTC and Consumer products throughout their lifecycle.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance...

  • Regulatory Affairs Specialist

    hace 5 días

    Barcelona, Barcelona, España The Health Club A tiempo completo

    Regulatory Affairs ManagerThe Health Club is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for ensuring the regulatory compliance of our OTC and Consumer products throughout their lifecycle.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance...

  • Regulatory Affairs

    hace 4 meses

    Barcelona, España Hays A tiempo completo

    **Tu nueva empresa** Nuestro cliente es una empresa en pleno crecimiento que se dedica a la investigación de ingredientes patentados para su aplicación en diferentes sectores: alimentación, salud y nutrición. **Tu nuevo puesto** Estamos buscando perfiles como Regulatory Affairs Manager & Regulatory Affairs Technician, cuyo objetivo será el de...

  • Regulatory Affairs

    hace 4 meses

    Barcelona, España Hays A tiempo completo

    **Tu nueva empresa**Nuestro cliente es una empresa en pleno crecimiento que se dedica a la investigación de ingredientes patentados para su aplicación en diferentes sectores: alimentación, salud y nutrición.**Tu nuevo puesto**Estamos buscando perfiles como Regulatory Affairs Manager & Regulatory Affairs Technician, cuyo objetivo será el de asegurar el...

  • Manager, Regulatory Affairs

    hace 2 meses

    Barcelona, España Innovaderm Research A tiempo completo

    The Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm's standard operating procedures, applicable regulations and good clinical practices and to the Sponsor's satisfaction.Responsibilities include providing leadership on regulatory activities that...

  • Regulatory Affairs Associate

    hace 1 mes

    Barcelona, España Meet Recruitment Limited A tiempo completo

    .Global Regulatory Affairs AssociateWe're currently seeking a Global Reg Affairs Associate for an award-winning pharma company specializing in OTC products! Preparing submissions of license variations, assisting in preparation of regulatory documents, acting as a submission specialist will all be core components of this role!The Regulatory Affairs Associate...

  • Regulatory Affairs Specialist

    hace 4 días

    Barcelona, Barcelona, España Meet A tiempo completo

    {"title": "Global Regulatory Affairs Manager", "description": "Job SummaryWe are seeking a highly skilled Global Regulatory Affairs Manager to oversee the regulatory process for our products, from development to post-market approval. The successful candidate will ensure compliance with applicable regulations and standards.Key ResponsibilitiesPrepare and...

  • Regulatory Affairs Specialist

    hace 4 días

    Barcelona, Barcelona, España Meet A tiempo completo

    {"title": "Global Regulatory Affairs Manager", "description": "Job SummaryWe are seeking a highly skilled Global Regulatory Affairs Manager to oversee the regulatory process for our products, from development to post-market approval. The successful candidate will ensure compliance with applicable regulations and standards.Key ResponsibilitiesPrepare and...