Global Regulatory Affairs Lead

Medella Life; Berlin; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

Medella Life is seeking a Global Regulatory Affairs Lead to develop and implement regulatory strategies for investigational new drugs in Germany or Switzerland. The role demands over 12 years of industry experience, including a deep understanding of regulatory processes in the EU and US. The ideal candidate will possess strong communication skills and the ability to lead interactions with health authorities while ensuring compliance across various departments. A Master's or PhD in the relevant scientific field is essential. This is an exciting opportunity to shape the future of drug development.

Qualifikationen

• At least 12-15 years of industry experience in global regulatory affairs.
• Strong understanding of regulatory framework for drug development.
• Experience in regulatory management systems and eCTD.

Aufgaben

• Responsible for planning and implementing the regulatory strategy for an investigational new drug.
• Manage the end-to-end process of creating the NDA and MAA.
• Leadership role during global health agency interactions.

Kenntnisse

Interpersonal communication

Writing skills

Flexible and initiative

Experience with large teams

Ausbildung

Masters in life sciences or PhD in health sciences/pharmaceutical sciences

Jobbeschreibung

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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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