Senior Consultant Regulatory Affairs & Publishing |Team Lead

📍Location: Warsaw – hybrid work
🕓 Type: Full-time

Join our Regulatory Affairs & Publishing team as a Senior Consultant and combine expert work on complex regulatory projects with a Team Leader role.

In this role, you will work on projects for clients in the Life Sciences sector, leveraging your RA expertise while also supporting the development of the team, coordinating its work, and sharing your knowledge.

This is an opportunity for an experienced RA professional who is open to expand their role to include responsibility for people, projects, and client collaboration.

🏢 What you’ll be doing

Regulatory Affairs

• 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.

Team Leadership

• Coordinate the work of the RA & Publishing team and support team members in the day-to-day delivery of projects;

• Provide technical support to the team and act as the first point of escalation for project- and team-related matters;

• Mentor, coach, and support the development of team members’ skills and competencies;

• Support the onboarding of new employees and foster a culture of collaboration and knowledge sharing;

• Support resource planning, prioritization, and workload balancing within the team;

• Collaborate with management to ensure effective project delivery and team development.

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;

• Experience in coordinating the work of others, mentoring, coaching, or leading a team/project;

• Fluent in Polish 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.

It’s more than a job – it’s a community where people grow, share positive energy, and have a real impact on what matters.

📩 Interested?
Send us your CV – you could be the next member of the QbD team!