Regulatory-Quality & Safety Manager

Regulatory Affairs/Clinical Affairs Rome, Italy


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

JOB/ROLE PURPOSE

Responsible for the hands-on Regulatory activity required to submit, approve and launch new products and the maintenance of existing commercialized. Projects are of moderate to high complexity.
Guarantee that the OTC range of medicines of the company are in line with the PV and quality legal requirements of registration, manufacture, distribution and preservation required by current legislation.

KEY RESPONSABILITIES

Regulatory Affairs :

  • Product portfolio: Medicines, Medical Devices, Biocides, Food Supplements and Cosmetics.
  • Assure national and international legislation up-to-date and compliance.
  • Strategic regulatory evaluation in line with business activities, regulatory intelligence, new registrations and maintenance of product authorisations, digital implementation, management of promotional and digital campaigns
  • Assist in execution of regulatory activities per the project plan to assure new product meet submission, approval and commercial launch goals.
  • Support manufacturing and procurement in the management of change to existing commercial products.
  • Maintain product labeling in compliance with laws and regulations; develop and approve label specifications in compliance with SOPs.
  • Process change requests in compliance with GMPs and regulations.
  • to define the best strategy and way forward for efficient product registration and marketing
  • Review and approve claims and advertising material.
  • Maintain a high level of Regulatory Knowledge, regarding current or pending regulations.
  • Attend to meetings with the Italian Health Authorities.

Pharmacovigilance Main Responsibilities:

  • Contribute and assist in global initiatives e.g. Change Management; Subject Matter Expert Committees; SOP Review Committees; Retention, Engagement, training, processes etc.
  • Develop and implement plans for measuring and improving employee engagement ensuring global consistency.
  • Manage Safety Operations staff in accordance with organization’s policies and applicable regulations.
  • Ensure direct reports are cross trained on Safety service offering; monitor and develop training plans.
  • Continuous improvement of department work processes, procedures and infrastructure.
  • Monitor and ensure that project processes and department deliverables meet expected quality, financial and productivity targets.
  • Ensure timely movement of project work through the process steps, in accordance with governing SOPs
Quality Assurance:
  • Responsible for the documentary system of Perrigo Italy: updated SOPs and in accordance with corporate SOPs.
  • Responsible for training in corporate SOPs: on time, file records and sending records to Corporate.
  • Training in GDPs for the employees of Perrigo Italy
  • Perform a mock-recall a year in case there has not been any real recall.
  • Carry out the supplier evaluation annually in conjunction with the Supply department.
  • Perform internal audits.
  • Audit the subcontracted warehouse.
  • Ensure that the storage and transport of medicines are carried out according to the GDPs.
  • Audit external suppliers and internal
  • Complete the Annual Quality Management Review.
  • Propose the CAPAs of the corporate audits received and perform the actions derived from the CAPAs.
  • Ensure compliance with the Quarantine Shipments.
  • Promote the system of deviations and CAPAs.
  • Guarantee that the changes that require it will be managed through a Change Control.
KNOWLEDGE & EXPERIENCE
  • Degree in Pharmacy.Chemistry,CTF, Medicine
  • Minimum experience of 5-7 years as responsible for Regulatory Manager
  • Experience in medicines, food supplements, medical devices, biocides and cosmetic products legislation
  • Excellent knowledge of the legislation and legal environment on OTC medicines
  • Indispensable fluent English, spoken and written.
SKILLS & ABILITIES
  • 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
  • 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 internal and external stakeholders

PERRIGO COMPETENCY MODEL
Inspires the Team, Develops Self/Develops Others, Customer Focus, Planning, Healthy Results, Collaboration & Influence, Takes Action, Continuous Improvement, Decision Making




We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.