Regulatory Affairs Professional

Job Title: Regulatory Affairs Manager

Debiopharm, a Swiss-based biopharmaceutical company, specializes in developing innovative therapies for oncology and bacterial infections. Our mission is to improve patient quality of life by addressing high unmet medical needs.

We are seeking an experienced Regulatory Affairs Manager to join our team in Martigny. As a key member of our regulatory department, you will be responsible for managing post-marketing regulatory activities, including renewals, CMC variations, and labeling updates.

• Maintenance of registration files for all post-approval activities.
• Authoring, reviewing, and leading high-quality documents for regulatory submissions.
• Preparing responses to questions raised by regulatory agencies.
• Providing expert content guidance for quality portions of the CTD, ensuring compliance with internal company standards and external regulatory guidelines.
• Coordinating with regional regulatory teams for global strategy.
• Defining, developing, and leading regulatory strategies for post-marketing activities.
• Assessing internal change controls.
• Maintenance and update of Product Information.
• Internal Regulatory contact for Pharmacovigilance and Marketing and Business.
• Keeping up-to-date with Regulatory Information Management System.
• Maintaining policy & regulatory intelligence.
• Providing regulatory strategies for projects as RA representative in cross-functional teams.

To be successful in this role, you will require:

• A degree in Science (e.g., Chemistry, Pharmacy) or equivalent.
• At least 3 years' experience in Pharmaceutical regulatory affairs for sterile parenteral chemical drugs, ideally prolonged-release formulation.
• Good knowledge of ICH Quality standards, European and US pharmacopoeias, International CMC Guidances, including ASEAN.
• Previous experience in meeting with Health agencies.
• Strong attention to details and organizational skills.
• Good written and oral communication, technical writing, and editing skills.
• Ability to handle different topics and willingness to learn.
• Demonstrate good interpersonal skills, ability to work with others in an international team environment, effective interactions in cross-department teams.
• Orientation for work result details, with emphasis on accuracy and completeness.
• Fluent in French and English.

The estimated salary for this position is CHF 80,000 - CHF 110,000 per annum, depending on experience.

We offer a comprehensive benefits package, including health insurance, pension plan, and paid time off.