Regulatory Affairs Specialist

Firmenname für PREMIUM-Mitglieder sichtbar

  • Mai 2021
  • nicht angegeben
  • CH-Switzerland
  • auf Anfrage
  • 08.04.2021
  • PR/105327_1617810741

Projekt Insights

seit wann aktiv?
Projektansichten
Bewerbungen

Projektbeschreibung

An exciting role has opened for a passionate regulatory affairs expert who would like to grow and develop their career towards post marketing projects globally if varied therapies.
Responsibilities:

* Coordinate, prepare or review regulatory submissions for all projects to include but not limited to new MAAs, variations and other associated life cycle maintenances submissions.
* Support and facilitate all life cycle maintenance activities with partner CROs
* Support assessment of change controls for the regulatory team
* Help with regulatory related questions and complaints
* Lead the artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging
* Review labelling (SPC, PIL and Labelling) for compliance against current EU guidelines and standards
* Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved effectively and on time.
* Coordinate review & approval of EU promotional material
* Maintain current knowledge base of existing and emerging regulations, standards or guidance documents
* Follow company policies and procedures
* Collaborate with team to establish and meet targets and timelines
* Help generate SOPs and Work instructions

Requirements:

* University degree in life science, pharmacy, pharmacology, medicine or related discipline and possible higher degree
* At least 3 years Regulatory Affairs experience
* Experience in filing new registrations via CP/DCP
* Experience in variations and life cycle management through European procedures (MRP/ National)
* Independent, reliable and communicative personality who can deliver high-quality work even under pressure and handle several projects simultaneously

Please send your CV.

Kontaktdaten

Als registriertes Mitglied von freelance.de können Sie sich direkt auf dieses Projekt bewerben.

Sie suchen Freelancer?

Schreiben Sie Ihr Projekt aus und erhalten Sie noch heute passende Angebote.

Jetzt Projekt erstellen