Regulatory Manager

☞ Manpower Switzerland

Aussicht: 162

Update Tag: 29-03-2024

Ort: Aesch (BL) Basel-Landschaft BL

Kategorie: Andere

Industrie:

Jobtyp: Full-time

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Jobinhalt

Mandated by our client company, we are looking for a Regulatory Manager, who will be responsible for managing and coordinating regulatory and strategic activities to company submissions (Pharma and IVDD, IVDR). This position will report to Head of Quality & Regulatory.

Responsibilities:

• Provide regulatory and strategic management to company submissions (Pharma and IVDD, IVDR)

• Liaison with Regulatory Authorities (EU, US, China, Japan)

• Effectively address regulatory issues that may surface during regulatory reviews and prepare and facilitate preparation of responses to Authorities in various countries worldwide

• Responsible for development and implementation of the Regulatory Strategy and Risk Documents

• Provide regulatory and strategic input on: development concepts and documents (e.g. dev plan, CTA/IND, briefing books, dossier documents); clinical study protocols and protocol amendments

• Convey critical knowledge, especially relating to assigned products to alleviate or reduce regulatory impacts and costs.

• Comply with applicable SOPs, GOPs and WIs

Requirements:

• BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Alternatively several years of regulatory or other relevant industry experience

• Fluent English required (oral and written)

• At least 3 years of relevant regulatory experience in Pharma and /or IVD

• Good understanding of regulatory requirements for drug development and IVD, clinical studies, dossier filings worldwide

• Experience in HA negotiations in different regions (EU, US, China, Japan)

• Strong interpersonal skills, team player

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Frist: 13-05-2024

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