Regulatory Affairs Associate Director, CMC

Overview

Located in Basel, Switzerland, we are seeking a dedicated professional to play an essential role in shaping and delivering global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies across a diverse portfolio of products.

Primary Responsibilities

• Contribute to the formulation and execution of global CMC regulatory strategies for assigned projects and products.
• Plan, coordinate, and support CMC submission activities, including the authoring, reviewing, and submitting of essential documentation.
• Identify documentation requirements and manage stakeholder alignment on content, quality, and timelines.
• Author and review high-quality CMC regulatory documentation, ensuring adherence to applicable guidelines and standards.
• Effectively communicate regulatory considerations, risks, and updates to cross-functional project teams and stakeholders.
• Support interactions with Health Authorities, including the preparation of briefing materials and responses.
• Collaborate across functions to enable consistent delivery and alignment on regulatory activities.
• Engage in continuous improvement initiatives and foster knowledge sharing within the regulatory community.

Key Qualifications

• Fluency in English, both written and spoken.
• A degree in a scientific discipline (e.g., Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent experience.
• Proven expertise in CMC Regulatory Affairs, including the regulatory submission and approval processes.
• Strong understanding of CMC regulatory requirements and the ability to navigate complex regulatory topics.
• Skill in evaluating scientific data across various disciplines and translating insights into regulatory decision-making.
• Working knowledge of pharmaceutical development, manufacturing, or related scientific domains.
• Ability to effectively collaborate and influence within cross-functional, global teams while managing multiple priorities.
• Excellent planning, organizational, and interpersonal skills, focused on quality, delivery, and continuous improvement.

Diversity and Inclusion Commitment

We are committed to fostering an outstanding, inclusive work environment and building diverse teams that reflect the patients and communities we serve.

Accessibility and Support

We strive to provide reasonable accommodation to all individuals. If you require assistance or additional information regarding the essential functions of a position due to a medical condition or disability, please reach out to our inclusion team.

Why Join Us?

Be a part of a community dedicated to making a difference. Together, we support and inspire each other to achieve breakthroughs that improve patients' lives. Join us in creating a brighter future.

Benefits and Opportunities

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