Regulatory Affairs Manager 100%

vor 3 Wochen

Basel, Schweiz Global Personal Partner Vollzeit

**EINFÜHRUNG**:
Our profession and our passion are "HR Management".

Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of services in the field of Human Resources at 21 locations in German-speaking Switzerland.

For our client, an international technology company in Basel, we are looking for a

**Regulatory Affairs Manager 100%**:
**AUFGABENBESCHREIBUNG**:
Regulatory Strategy:

- Responsible for managing operational activities of assigned early development projects
- Provides input into global regulatory strategy and contributes to the Integrated Development
- May serve as local HA liaison depending on location (e.g., FDA or EMA)

Submissions and Approvals:

- Responsible for managing timely submission and approval of dossiers with HAs under the guidance of the DRA ED Head, keeping the franchise head/GTAL in the disease area in the loop
- Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), and CTAIND-related maintenance activities such as amendments, annual safety reporting end of trial notifications, submission of CSR etc.
- Review and comment on key messaging and integration of early submissions, IBs, and other summary documents

**ERFORDERLICHES PROFIL**:
Requirements:

- Science-based BS or MS with the requisite experience and demonstrated
- capability. An advanced degree (MD, Ph.D., PharmD) is a plus. A background in basic science or toxicology is preferred
- Languages: Fluency in English as a business language. Additional language is an asset

**Experience**:

- Experience with regulatory submission and approval processes in 1 or more major regions
- Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry
- Experience in HA negotiations minimum of 2-4 years of involvement in regulatory and drug/biologic development spanning activities in Early Development and Phases I-IV
- Strong interpersonal, communication, negotiation, and problem-solving skills

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