Regulatory Affairs Specialist – 6482 ADA

Our client is a leading global player in the Pharmaceutical industry covering multiple therapeutic areas, with global headquarters in Basel, Switzerland.

For them, we are currently looking for a Regulatory Affairs Specialist in Solothurn, Switzerland. This is a contract role until the end of 2025 with potential yearly extension.

As a Regulatory Affairs Specialist, you will lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, under minimal supervision. You will guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. You would also help to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. In this role, you will be assisting in the development of best practices for Regulatory Affairs processes.

In addition, you may be involved in providing independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches.

Main Responsibilities:

• Ensure compliance with regulatory agency regulations and interpretations.
• Prepare responses to regulatory agencies' questions and other correspondence.
• Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
• Involve with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Provide solutions to a variety of problems of moderate scope and complexity.
• Research, collect data, and respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.
• Prepare regulatory labeling requirements specifications for new and modified products, and review product labeling to ensure compliance.
• Provide regulatory guidance to product development teams and responds to product information requests.
• Provide Regulatory Affairs support during internal and external audits.
• Assist in the development of best practices for Regulatory Affairs processes.
• Represent Regulatory Affairs on cross-functional project teams.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• A minimum of a bachelor’s degree is required.
• 2-4 years of regulatory affairs or related/equivalent experience
• Excellent written and oral communication skills.
• Excellent organizational skills preferred.
• Ability to handle multiple tasks and be detail oriented.
• Ability to apply risk-benefit analysis techniques.
• RAC certification for Medical Devices preferred.