Junior Nonclinical Regulatory Affairs
Junior Nonclinical Regulatory Affairs
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Job Description
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 Diversit Evotec tudie comptences gales 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.
Required Experience:
Junior IC
Employment Type
Full-Time
