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.
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.
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