Manager, Regulatory Affairs – Development CMC
United States
Job Description
- 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.
Requirements
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.
Apply
Career Focus: Analyst, Regulatory, Regulatory/Compliance
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