Consultant RA - Nonclinical & Clinical

Location : Hybrid / EU-Wide

Type : Full-time

Do you enjoy working at the intersection of science, regulation, and market access?
Do you like turning complex regulatory requirements into clear, actionable documentation that supports bringing medicines to patients?

In this role, you will contribute to regulatory strategies and documentation across the product lifecycle, working closely with experienced regulatory experts in an international environment.

What you’ll be doing

• Authoring, updating, or verifying the nonclinical and clinical parts of registration dossiers for medicinal products (in accordance with legal requirements and ICH/EMA/FDA guidelines), or documentation for variation applications to marketing authorization

• Authoring, updating, or verifying of the administrative part of the CTD Module 1 in particular Product Information (e.g., Package Leaflets, Summary of Product Characteristics, Labeling)

• GAP analyses of nonclinical and clinical registration dossiers for medicinal products

• Regulatory analyses; assessing the possibilities and methods of introducing medicinal products / medical devices to the market

• Assessing the possibility of OTC (over-the-counter) switches for medicinal products · Preparation of business proposals under the supervision of more senior experts

• Basic Project Management activities

What you bring

• Higher education in pharmacy, medicine, biology, biotechnology, or a related field

• Advanced English (spoken and written – level B2/C1)

• Practical knowledge of MS Office (Word, Excel, PowerPoint); previous experience with MS365 and cloud solutions will be an advantage.

• Proficiency in searching and analyzing literature data

• Ability to clearly formulate thoughts and conclusions, both orally and in writing

• Independence, ability to prioritize and organize work

• Knowledge of statistical software (e.g., SAS, Statistica) will be an advantage

• Accuracy and meticulousness in preparing / verifying documents

What’s in it for you?

Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices

Grow within a community of experts:  Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.

Build a meaningful career:  As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.

A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued.

Who you are

Our culture is driven by values If this sounds like you, you’ll fit right in:

• You’re resilient and tackle challenges with a positive mindset

• You’re curious and always up for learning something new

• You have a no non-sense approach honest, clear, respectful

• You’re innovative and bring ideas, not just opinions

• And above all, you’re serious about your work, but not too serious about yourself

✨ About us

We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 700 experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma. Since January 2025, SciencePharma has been part of QbD Group, joining forces to deliver comprehensive end-to-end solutions.

We believe in JPEG :
Joy. Partnership. Going the Extra Mile. Getting Things Done.

You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.

Interested? Let’s talk.
Send us your CV - You could be the next one to join the QbD family.