Ra Manager

vor 2 Wochen

Basel, Schweiz Proclinical Staffing Vollzeit

Proclinical is seeking a Regulatory Affairs Manager to join our client's team in Basel, Switzerland. This role focuses on supporting regulatory submissions for biological medicinal products within the dermatology sector. You will play a crucial role in ensuring compliance and facilitating communication with health authorities.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

**Responsibilities**:

- Author and review CTD module 3.2 sections for drug substances and products.
- Manage responses to Health Authority questions and draft briefing documents.
- Lead and coordinate activities to meet submission deadlines.
- Communicate and escalate risks and issues to management.
- Act as the regulatory point of contact for assigned projects.
- Perform regulatory assessments for change controls and deviations.
- Support site-specific regulatory documentation and activities.
- Participate in process improvement projects to enhance regulatory processes.

**Key Skills and Requirements**:

- Advanced knowledge in Life Sciences and Pharmaceutical Sciences.
- Strong understanding of CMC requirements for biologics.
- Experience in authoring CMC CTD sections for biological products.
- Strong organizational and project management skills.
- Ability to work both autonomously and collaboratively.
- Excellent communication and interpersonal skills.
- Analytical and learning skills.
- Previous experience in a contractor environment is advantageous.
- Proficiency in MS tools like Word, Excel, and SharePoint.
- Bachelor's or master's degree in relevant fields; higher education preferred.
- Fluency in English; German is a plus.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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