Senior Consultant Regulatory Affairs

QbD Group; Warszawa; Hybrid; PLN 393,000 - 524,000; Full time

Benefits offered by this job

Private healthcare

Flexible benefits platform

Lunch card

Group life insurance

Employee referral programme

Job summary

QbD Group is seeking an experienced Regulatory Affairs professional to lead multidisciplinary regulatory projects across European markets. You will advise on lifecycle management, manage submission processes, and work with Health Authorities and clients to deliver compliant solutions.

The role requires a university degree in Pharmacy or Life Sciences, 8+ years in Regulatory Affairs, and fluency in Polish or Spanish and English.

Qualifications

• Lead complex regulatory projects and advise on lifecycle management.
• Coordinate preparation, review and submission of regulatory docs.
• Support clients in resolving regulatory matters with Health Authorities.
• Strong communication and organizational skills required.

Responsibilities

• Lead complex regulatory projects and provide lifecycle management advice.
• Coordinate regulatory documentation preparation, review and submission.
• Support clients and respond to Health Authority queries.
• Ensure timely delivery within scope and budget.
• Collaborate with clients and internal teams for smooth delivery.

Skills

Regulatory project leadership

European regulatory procedures

Client communication

Project management

English language

Polish/Spanish bilingual

Education

University degree in Pharmacy / Life Sciences

Job description

Location: Hybrid - Madrid or Warsaw
Type: Full-time

We are looking for an experienced Regulatory Affairs professional to join our growing team and play a key role in delivering regulatory services to our clients across European markets.

This position offers the opportunity to manage complex regulatory projects, advise on lifecycle management, national and European procedures, work closely with clients and Health Authorities, build and contribute to our business growth in a collaborative, international consulting environment.

What you’ll be doing

• Lead complex regulatory projects and provide advice on lifecycle management, national and European procedures;

• Coordinate the preparation, review, and submission of regulatory documentation;

• Support clients in resolving complex regulatory matters and responding to Health Authority queries;

• Ensure the high-quality and timely delivery of projects in line with regulatory requirements, scope, and budget;

• Collaborate with clients and internal teams to ensure the smooth delivery of projects.

Client & Business Support

• Build and maintain long-term client relationships and contribute to client satisfaction;

• Participate in proposal preparation and discussions regarding the scope of cooperation;

• Support business development activities, including identifying opportunities to expand collaboration with existing clients.

What you bring

• University degree in Pharmacy, Life Sciences, Biotechnology, or a related field;

• Minimum 8 years of experience in Regulatory Affairs;

• Very good knowledge of European regulatory procedures and lifecycle management;

• Experience in managing complex regulatory projects;

• Fluent in Polish or Spanish and English, both spoken and written;

• Excellent communication and organizational skills, with the ability to set priorities;

• Independence, accountability, and strong problem-solving skills;

• Experience working with international clients and in a consulting environment would be an advantage.

What’s in it for you?

Make a real impact – you help shape the future of the Life Sciences industry by combining strategic regulatory consulting with team leadership and the delivery of international client projects.

Grow within a community of experts – you benefit from knowledge sharing, mentoring, and a variety of ambitious challenges that develop both your regulatory expertise and leadership skills.

Build a meaningful career – as an ambitious and innovative company, we aim to provide the best possible environment for your development in the Life Sciences industry. We offer career progression opportunities, language learning, and internal training.

A fair, competitive package – you will have access to private healthcare, a flexible benefits platform with a sports card, a lunch card, group life insurance, and an employee referral programme.

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, providing tailored solutions across development, clinical research, regulatory affairs, quality, manufacturing, and distribution. A team of more than 700 experts across 8 countries actively contributes to the development of innovation in areas including ATMPs, biotechnology, medical devices, diagnostics, digital health, and pharmaceuticals. Since January 2025, SciencePharma has been part of QbD Group, enabling us to jointly offer comprehensive 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.