Regulatory Development Manager - Canton Ticino

Job content

On behalf of a fast growing pharmaceutical company I am currently looking for a Regulatory Development Manager experienced within due diligence activities in early and late-stage product development (EU/US, mainly) and in pre-submission meetings with HAs (FDA, EMA and EU HAs) to define regulatory strategy for NDA, centralised, and decentralised procedures.
The successful candidate will report directly to the Corporate Regulatory Affairs Manager and supervise and mentor the Regulatory Team.
He/She will also collaborate with the various internal functions external stakeholders (CMOs, commercial partners, etc.).

The company is a pharmaceutical company delivering injectable anaesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing.

Tasks and Responsibilities:
Establishing a strategy from development to registration and supporting the execution (directly and/or through supervising the operational resources) of the global regulatory affairs lifecycle and manage approved registrations through collaborating with the various internal and external stakeholders (CMOs, commercial partners, etc.).
Overseeing development projects and performing Due Diligence activities to evaluate regulatory risks and opportunities.
Identifying in advance potential hurdles that might impact the regulatory success of development activities and/or potential licensing in processes.
Supporting the Regulatory Corporate Manager in IND, NDA, and ANDA strategy preparation, involving and training the RA Team members responsible for operational activities.
Providing operational support with strategic regulatory documents to help drive timely deliverables.

Skills and Competences:
Solid scientific background (BSc, MSc, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine).
At least 10 years experience in regulatory affairs preferably in global/HQ positions and/or across different geographic locations.
Deep knowledge of drug development processes, European regulations, FDA regulations and procedures.
Consolidated Experience in performing due diligence activities in early and late-stage product development (EU/US, mainly) and in pre-submission meetings with HAs (FDA, EMA and EU HAs) to define regulatory strategy for NDA, centralised, and decentralised procedures.

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