Regulatory Affairs Manager & Pharmacovigilance (Deputy LCP)

Regulatory Affairs Manager & Pharmacovigilance (Deputy LCP)

Perrigo

Barcelona, Spain

DESCRIPTION:

Responsible of handling regulatory activities required to submit, approve and launch new products and the maintenance of marketed goods from the assigned brands. Moderate to high complexity projects.

To ensure that the Pharmacovigilance legislation is fulfil at local level.

Regulatory Affairs

  • Execution of regulatory activities to assure new products meet submission and approval timings to comply with commercial launch goals.
  • Support on manufacturing and modifications management of existing products already marketed.
  • Ensure the compliance of the regulations in product labeling; following the procedures described in the company’s SOPs.
  • Perform change requests in compliance with GMPs and regulations.
  • Maintain regulatory files and data systems in compliance with SOPs.
  • Represent local Regulatory Affairs from Spain in project meetings.
  • Collaborate with the Technical Department of Perrigo Spain to define the best strategies and ways for efficient product registrations and launches in Spain.
  • Review and approve claims and advertising materials.
  • Maintain a high level of regulatory knowledge, considering current or regulations pending to be approved.
  • Attend meetings with Spanish HA to push dossiers or variations approvals.

Pharmacovigilance

  • Perform LCP activities and be LCP back up if needed.
  • PV Quality system.
  • Contact details.
  • SOPs.
  • Legislation.
  • Compliance.
  • Document management.
  • SharePoint.
  • Communication.
  • Communication with competent authorities.
  • Communication regarding service providers.
  • Agreements.
  • Training.
  • IT.
  • 24 hour coverage.
  • Business continuity.
  • Inspection/audit.
  • Licenses.
  • Safety reports.
  • Studies.
  • Social media.
  • Medical Enquiries.
  • Literature search.
  • Periodic Safety Updated Reports.
  • Renewals
  • Risk Management.
  • Signal Management.
  • Company Core Safety Information (CCSI)/Company Core Data Sheet (CCDS).

REQUIREMENTS:

  • Degree in Pharmacy.
  • Minimum experience of 3 years in/Regulatory Affairs/Pharmacovigilance department.
  • Experience in medicines, food supplements, medical devices, biocides or cosmetic legislation will be valued.
  • Excellent knowledge of how the Regulatory Department contributes to Business Development.
  • Indispensable fluent English, spoken and written.
  • Combination of leadership (impact/influence, strategic vision) skills with technical knowledge and records.
  • Communicative skills and Results Orientation.
  • Innovative and Analytical Thought.
  • Agile and ability to adapt to changes.
  • Project Management Capacity/decision making/ ability to negotiate.
  • Team spirit.
  • Persistent in the search for results on shorter paths.
  • Organized and resolutive.
  • Interest to work in a global company.
  • Previous experiences how to work successfully in a matrix structure would be preferred.
  • Passion/interest for selfcare products.
  • Interest to collaborate closely with other stakeholders (locally & centrally).

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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