We are seeking a highly motivated and detail-oriented professional to join our Regulatory Affairs team as a Regulatory Affairs Specialist with a focus on Nonclinical Regulatory expertise. This role offers an excellent opportunity to contribute to the preparation of key regulatory submissions and to collaborate across multidisciplinary teams in a dynamic and evolving environment.
Key Responsibilities:
- Prepare and review Nonclinical Tabulated Summaries, in accordance with Notice to Applicants, Vol. 2B – CTD, Module 2 Templates.
- Draft and critically review nonclinical regulatory documentation to support CTA/IND submissions in compliance with applicable guidelines and timelines.
- Participate in selected project team meetings, providing regulatory input on nonclinical aspects and ensuring alignment with global regulatory strategies.
- Maintain current knowledge of global regulatory requirements relevant to nonclinical development and ensure timely communication of key changes to internal stakeholders and senior leadership.
- Support the development, implementation, and continuous improvement of the Regulatory Affairs Quality System, including the definition and maintenance of internal processes and standard operating procedures (SOPs).
Ideal Candidate Profile:
- Demonstrates a proactive and collaborative mindset, with strong organizational and communication skills.
- Previous experience in nonclinical regulatory writing and submission planning is an advantage, though not mandatory.
- A strong scientific background (e.g., life sciences, pharmacology, toxicology, or related field) is preferred.
- Excellent command of written and spoken English is required.
- Comfortable working both independently and within cross-functional teams, in a hybrid setting (in-person and remote collaboration).
We are looking for individuals who are eager to grow professionally, contribute to regulatory excellence, and work in a stimulating, team-oriented environment. If you are adaptable, committed to quality, and ready to make an impact in regulatory development, we encourage you to apply.
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
