Senior Consultant Regulatory Affairs & CMC |Team Lead

Location: Warsaw & Madrid/Barcelona hybrid work
Type: Full-time

CMC Activities

• Lead complex CMC projects and provide strategic advice on pharmaceutical development manufacturing testing lifecycle management and global regulatory requirements;

• Coordinate the preparation review and submission of CMC documentation for regulatory applications and post-approval variations including documentation supporting clinical trial applications marketing authorization applications and lifecycle management activities across centralized decentralized and national procedures;

• Support clients in resolving complex CMC-related matters and responding to Health Authority questions and requests;

• 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;

• Provide technical expertise in drug substance and drug product development and lifecycle management supporting regulatory submissions throughout the product lifecycle including clinical development marketing authorization and post-approval variations.

Team Leadership

• Coordinate the work of the CMC 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 strong 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 denitrifying opportunities to expend collaboration with existing clients

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

• Minimum 8 years of experience in CMC Regulatory Affairs pharmaceutical development manufacturing quality or a related field;

• Very good knowledge of CMC requirements for development registration and lifecycle management of medicinal products;

• Experience in managing complex CMC projects;

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

• Fluent in 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: 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.

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.

You wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.

Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.