Global Regulatory Affairs Lead

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Recruitment Consultant - Regulatory and Quality DACH region

Title: Global Regulatory Affairs Lead Department: Regulatory Affairs Regional coverage: US and Europe

Must be based in Germany or Switzerland

Role Objectives:

• Responsible for planning and implementing the regulatory strategy for an investigational new drug with the aim to secure an NDA and MAA approval

• Responsible for planning, executing, and coordinating all regulatory activities specifically the pre-NDA meetings with the USFDA and the EMA Scientific Advice discussions

• Manages the end-to-end process of creating the NDA and MAA including coordination with various internal departments as well as the HA and providing guidance and insights through the same

• Experience in regulatory management systems, eCTD and other tracking systems will be a plus

Job Description:

• At least 12-15 years of industry experience, with 10+ years in global regulatory affairs including regulatory strategy, planning and execution for the launch of investigational new drugs in global markets.

• Strong understanding of the regulatory framework for drug development spanning activities from quality, non-clinical development and clinical development including the approval processes especially for the US and Europe markets

• Should have the knowledge and application of regulatory guidance of the process of securing an approval for investigational drugs / biologics, delivering regulatory intelligence and insights through the process

• Leadership role during global health agency interactions for early and late-stage development programs including proposing approaches and organizing pre-NDA meetings with the US FDA, exploring opportunities to engage in Scientific Advice with the EMA in order to facilitate the dialogue and validate the application process

• Facilitate the NDA/MAA complication process by planning and coordination across various departments involved and provide regulatory insights through the submission process

• Serve as a single point of contact for internal and external stakeholders involved in the NDA/MAA process as well as the Health Authorities

• As a regulatory lead, participate in cross functional and product development discussions

• Keep updated on the latest regulatory guideline changes which might have an impact in the submission process

• Work within a controlled, matrix environment governed by applicable SOPs and procedures

Education:

Masters in life sciences domain (e.g., Pharmacist by qualification) or hold a PhD in health sciences or pharmaceutical sciences

Skills:

• Strong command on English, interpersonal communication and writing skills

• Flexible with a high level of initiative

• Experience of working with large dynamic teams

• Standard skills as those expected from a regulatory experienced professional.

Location / Travel:

• Switzerland or Germany

• Potential for limited occasional travel

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Consulting

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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