Regulatory & Quality & Safety Affairs
Barrington James
Czech Republic
před 1 dnem

Job outline

An exciting opportunity to join a dynamic, game-changing team within a rapidly growing healthcare company with a diverse portfolio.

The role scope is to be the functional country head of the regulatory , quality and safety operations in Czech and Slovak Republic.

The role will attract a high level of autonomy and responsibility for management of workload and priorities. This person will lead the regulatory, quality, safety team in CZ and SK , aiming to be best in class in the industry, and will be visible to senior levels of the local and international business.

Key Responsibilities

  • Enabling Commercial Strategy : Ensure development of local regulatory strategy for new product registration & licence maintenance, fully aligned to business needs.
  • Actively contribute to and define claims-support rationale, to obtain the strongest commercial platform possible.

  • Ensuring compliance : with all legal obligations in the area of drugs, medical devices, food supplements , cosmetics and biocides .
  • Ensuring vigilance for the local product portfolio of the company for all types of products (pharmacovigilance, medvigilance , materiovigilance etc) and full compliance with QA requirements.

    Including oversight, identification, training and monitoring of process improvements and ongoing-compliance.

  • Oversees and ensure establishment and maintenance of quality : CE certification, ISO 9001, ISO 13485. Ensuring compliance with GDP and supervise all relevant local quality operations and systems including local batch release and audits etc.
  • Supervise the quality of contract manufacturing.

  • Internal Stakeholder Management : Effectively manage expectations across a broad range of business stakeholders, employing high quality communications in all interactions.
  • External Relations : Continue to build strong relationships with Regulatory Authorities, Trade Associations & Key Opinion Leaders, forming a go-
  • to network for strategy development and problem solving. Ensure communication with state health authorities in the area of all product types in the local portfolio.

  • The role reports to the Head of Regulatory Affairs & Quality & Safety Services -Europe East region , and will be based in the office in Brno.
  • Person Specification

    Education & experience required :

  • Educated to degree level within life sciences. Pharmacist degree is beneficial.
  • Substantial experience (6+ years) working within regulatory affairs, ideally within OTC
  • Experience includes Medicines and Medical devices; with Medicines experience spanning new MAAs (with awareness of National Procedures / DCP / MRP), as well as management of line extensions and licence maintenance activities.
  • Experience with Traditional Herbal Medicinal Products, Biocides, Food Supplements, Veterinary Products and Cosmetics would also be beneficial.
  • Strong experience (2+ years) within Quality affairs for medicines and medical devices and cosmetics. Good understanding and experience with GMP & GDP and ISO requirements.
  • Extensive involvement in the generation / review of product claims and advertising materials across product types.
  • Experience with Pharmacovigilance and materiovigilance systems
  • Fluent English
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