Regulatory Affairs Expert Verona

Regulatory Affairs Expert
Verona
Veneto, Verona

ABOUT EVOTEC SE

Evotec is a life science company with a unique business model focused on providing access to highly effective new therapeutics.

The Company leverages its multimodality platform with a unique set of innovative technologies for both proprietary and partnered projects.

The Nonclinical (NC) Regulatory expert is responsible for supporting the NC-related regulatory aspects of selected projects within Evotec.

He/she will participate in the definition of the nonclinical regulatory strategies for internal or customer's projects in collaboration with the integrated drug development and cross-functionally.

He/she will be in charge (directly or by managing third parties) of the preparation of nonclinical-related regulatory documents such as, but not limited to, Investigational New Medicines (IND), IMPD, Investigator's Brochure, Briefing Documents in support of health authority meetings, as required, in line with assigned timelines.

He/she liaise, advise, and collaborate with nonclinical departments to define the data and the reports needed in support of the regulatory documents' preparation.

Perform assigned work according to current best regulatory practice and in compliance with current legislation and regulatory guidelines.

**Responsibilities**:

- Support the NC-related regulatory aspects of the projects within Evotec by participating to the definition of the regulatory strategies as far as the NC aspects are concerned

- Lead the preparation, revision, and final edition of the regulatory NC documents directly or managing third parties

- If needed, review the client's nonclinical documents

- Liaise and collaborate with other Evotec or Client's functions and Consultants for a successful edition of the regulatory documents, by assessing the adequacy and the availability of relevant background documents and data in support of the regulatory documents' preparation

- Ensures the final NC regulatory documents for submission are complete, accurate and consistent with company/client objectives and in line with the most updated local regulations.

- Contributes to the creation and maintenance of the Regulatory Affairs quality system collaborating to the definition of processes and implementation of standard procedure

- Maintain up-to-date knowledge of regulatory requirements and communicate changes to the relevant stakeholders and senior management in a timely manner.

QUALIFICATIONS and SKILLS

- Pharmaceutical Science, Pharmacy, Biotechnology, Biology (or related scientific disciplines) degree or PhD

->5 years of experience in nonclinical drug development or Regulatory Affairs, with a strong knowledge of nonclinical development in biologics, anti-sense oligonucleotides and peptides, and edition of regulatory documents or specific study reports and summary documents

- Strategic thinking, problem solving attitude, good technical background, integrity, and project management skills

- Good knowledge of EMA, ICH and FDA regulations, guidance, and regulatory processes pertaining to drug development and approval

- Self-motivated with a high degree of initiative and sense of urgency

- Ability to work independently, under stress pressure, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on environment

- Excellent communications skills (verbal, written, listening, conveying messages)

- Goal and action-oriented, with excellent time management and organizational skills

- Detail-oriented, result-driven, with high degree of accuracy and quality of deliverables

- Strong knowledge in MS Office (Word, Excel, and PowerPoint), Adobe Acrobat and Microsoft SharePoint (preferred)

- Fluent in English spoken and written

Middle Management