Senior Consultant Regulatory Affairs & Publishing |Team Lead

Location: Warsaw & Madrid/Barcelona 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.

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.

• 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 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.
  

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.

Our culture is driven by values If this sounds like you youll fit right in:

• Youre resilient and tackle challenges with a positive mindset

• Youre curious and always up for learning something new

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

• Youre innovative and bring ideas not just opinions

• And above all youre serious about your work but not too serious about yourself

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.

Its more than a job its 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!