Regulatory Affairs Specialist M/F

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Regulatory Affairs Specialist / Basel, Switzerland / CHF 850-1050 per day

Darwin Recruitment has a new vacancy at one of our clients located in Basel, Switzerland where we are looking to hire a temporary RA Specialist to start as soon as possible.

General Conditions
Start Date: October 2023 (ASAP)
Location: Basel 1 day per week / Home office 4 days per week
End Date: December 2024 / + extensions (project duration 18-24 months)
Day Rate: Depends on experience. Approx CHF 850-1050

We are currently seeking a Regulatory Affairs Specialist to join our team and play a pivotal role in supporting regulatory initiatives within the RA Platform.

As a Regulatory Affairs Specialist, your responsibilities will encompass a wide range of regulatory activities, including but not limited to:

1. Pre-licensing Activities: Assisting in the process of obtaining new registrations for sites and medicinal products.

2. Post-licensing Regulatory Activities: Managing all aspects of LifeCycle Management activities post-licensing.

3. Health Authority Interactions: Engaging with health authorities on behalf of our valued PLG customers.

In addition to these core responsibilities, you will also have the crucial role of providing support during external and unannounced audits, promptly responding to internal requests for technical and regulatory information, and ensuring strict compliance with all regulatory processes to prepare for both internal and external audits.

Key Technical Skills Required:

• Consultancy-Level Expertise: Ability to provide expert input for the CH region on a diverse range of topics.

• Regulatory Framework: A deep understanding of the regulatory framework specific to the CH region (DACH expertise is highly desirable).

• Marketing Authorization Applications: Proficiency in preparing Marketing Authorization Applications tailored to the CH region.

• Post-Approval Applications: Experience in crafting and submitting documentation for post-approval applications in the CH region.

• Technical/Site Transfer Applications: Competence in preparing and submitting Technical/Site Transfer Applications.

• Swissmedic Experience: Direct experience with Swissmedic, and if possible, familiarity with BfArM and PEI.

• Scientific Advice Coordination: Proven experience in coordinating and leading Scientific advice meetings.

• Licensing Proficiency: Demonstrated expertise and knowledge in licensing, especially for Novel Medicines, Biologicals, Orphan Drugs, and considerations related to Pediatrics.

• Software Proficiency: Proficiency in using various software packages for document creation, spreadsheet management, database maintenance, and information retrieval.

• Timely Delivery: A track record of consistently delivering results within tight timelines without compromising quality or exceeding departmental budgets.

Desired Soft Skills:

• Language Proficiency: Fluent in English

• Organizational Skills: Excellent organizational skills to manage complex regulatory tasks efficiently.

• Communication Skills: Outstanding communication skills to facilitate effective interactions with various stakeholders.

• IT Skills: Adeptness with IT tools and knowledge.

• Proactive Approach: A proactive attitude with the ability to work independently or as part of a team.

• Quality Focus: Personal responsibility for maintaining high standards of work.

• Consultancy Experience: Previous experience in a consultancy environment is advantageous.

• Access Consortium and Project Orbis: Knowledge and experience with Access Consortium and Project Orbis would be beneficial.

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

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