• Provide CTA support for various early development projects.
• Work on diverse regulatory CMC projects, including development activities and NDA filings for biologics (e.g., mAbs, E. coli).
• Contribute to global regulatory strategies with a focus on creativity and innovation, ensuring business benefits while maintaining compliance.
• Author and prepare regulatory submissions aligned with client-specific global strategies, meeting or exceeding expected timelines.
• Prepare responses to health authority queries during development and registration.
• Work with RIM systems, such as Veeva Vault RIM.
• Identify and track required documentation for global submissions, coordinating technical document delivery in line with project timelines.
• Flag potential issues with source documents that may impact submission quality or timelines, and communicate effectively with client stakeholders to ensure clarity and comfort.
• Stay up to date with global regulatory guidelines, trends, and emerging topics to provide informed, cutting-edge advice.
• Actively contribute to development teams by shaping regulatory strategies, identifying critical issues, and applying lessons learned.

Our Ideal Candidate:

• 5–10 years of broad regulatory experience, ideally with both small and large molecule products. Our projects are diverse, so we need someone who can adapt to a variety of challenges.
• Expertise in European regulatory affairs, including regulatory strategy, CMC knowledge, dossier compilation, and post-approval maintenance. Experience with emerging markets and global regulations is a plus.
• Strong familiarity with ICH, EMA, and US FDA guidelines and procedures.
• Ability to work effectively with multinational teams and manage multiple projects simultaneously under tight deadlines.
• Excellent planning, organizational, and interpersonal skills.
• Strong written and verbal communication skills, with the ability to negotiate effectively.
• A BSc, MSc, or PhD in a life sciences field.

Personality Traits:

Your workload will be fluid and driven by client needs—no two projects are alike.

We’re looking for someone who is an excellent communicator, a selfless team player, and a brilliant multitasker.

Most importantly, we want someone with a great sense of humor!

We strive for a positive, fun work environment while delivering exceptional services to our clients.

If you have a “can-do, why-not” attitude, we’d love to hear from you.