Regulatory Affairs Senior Specialist

Morgan Philips

  • Madrid
  • Permanente
  • Tiempo completo
  • Hace 2 meses
  • Solicite fácilmente
We are recruiting a Regulatory Affairs Senior Specialist for an important pharmaceutical company with the following responsibilities:

Responsibility

Support new regulatory submissions and assisting with the lifecycle management of the existing portfolio making sure that any variations and/or renewals will be submitted in time to ensure regulatory compliance

Specific Responsibilities
  • Prepare eCTD documents
  • Provision of samples and CPPs to the local affiliates
  • Archiving of essential documents, such as Product Information and ensure quality part of the dossier are archived and updated in line with company procedure
  • Support and provide the necessary documentation to local affiliates for national submissions
  • Make sure that the essential information from the dossier post approval are shared with implicated departments according to relevant procedures
  • Prepare the necessary documentation needed for submission of administrative variations
  • Prepare the necessary documentation needed for submission of quality related variations
  • Compile and prepare the necessary documentation needed for submission of safety variations in liaison with pharmacovigilance department
Competencies/Career level Innovation, customer orientation, communication, team work, adaptability/flexibility, productivity, Self-development, sense of urgency, initiative.

Requirements and personal skills
  • Education: Degree in Health Sciences (preferably Pharmacy, but also Chemistry, Biology, Biochemistry, Veterinary or similar).
  • Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
  • Experience (years/area): +4 years of experience in the regulatory department of a pharmaceutical industry
  • Specific Knowledge: Knowledge in Module I - IV Experience in management and team coordination Technical Records. Preferably have previous connection with generic or branded generics (copies). Knowledge of International Standards in terms of drug registration. Experience decentralized records. Knowledge of international markets and distribution business is desirable.
  • Travels: Willingness to travel.
Contact

Eva Santos
+34 91 787 93 00
Morgan Philips Executive Search
Paseo de la Castellana 141, 17º
28046 Madrid
España

Morgan Philips

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