Regulatory Affairs Manager & Pharmacovigilance (Deputy LCP)

Regulatory Affairs/Clinical Affairs Sant Cugat del Vallés, Barcelona, Spain


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.

While a solid corporate reputation is developed over years, it must be nurtured through our day-to-day activities:
Integrity, We do what is right.
Respect, We demonstrate the value we hold for one another.
Responsibility, We hold ourselves accountable for our actions.

Perrigo has always been committed to Diversity & Inclusion (D&I) as demonstrated through our core values, policies, practices, and everyday interactions. Prioritizing D&I helps us continue to be an employer of choice and enables us to better compete with other consumer packaged goods companies in the self-care space.

TOGETHER, we make lives better. 

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)

 

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.