Senior CMC Regulatory Lead & Team Mentor

SciencePharma; Warszawa; On-site; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Competitive package

Global exposure

Job summary

SciencePharma in Poland seeks a senior Lead in CMC Regulatory Affairs to steer complex projects across development, manufacturing, testing, and lifecycle management, ensuring compliance with global regulatory requirements.

You will coordinate submissions for clinical trials, MAAs, and lifecycle variations, mentor a cross-functional team, and build strong client relationships while delivering high-quality, on-time results.

Qualifications

• University degree in Pharmacy, Chemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or related field.
• Minimum 8 years of experience in CMC Regulatory Affairs or related field.
• Fluent in English (spoken and written).
• Experience managing complex CMC projects.

Responsibilities

• Lead complex CMC projects and provide strategic advice on development, manufacturing, testing, lifecycle management, and global regulatory requirements.
• Coordinate preparation, review, and submission of CMC documentation for regulatory applications and post-approval variations.
• Support clients in resolving complex CMC matters and respond to Health Authority questions and requests.
• Ensure high-quality, timely delivery of projects within scope and budget.
• Collaborate with clients and internal teams to ensure smooth delivery of projects.
• Provide technical expertise in drug substance and drug product development and lifecycle management throughout the product lifecycle.
• Coordinate the work of the CMC team and support team members in day-to-day delivery.
• 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 onboarding of new employees and foster 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.

Skills

CMC regulatory affairs

Regulatory project leadership

Team mentoring

English proficiency

Communication skills

Client relationship management

Education

University degree in Pharmacy, Chemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences or related field

Job description

SciencePharma in Poland seeks a senior Lead in CMC Regulatory Affairs to steer complex projects across development, manufacturing, testing, and lifecycle management, ensuring compliance with global regulatory requirements.

You will coordinate submissions for clinical trials, MAAs, and lifecycle variations, mentor a cross-functional team, and build strong client relationships while delivering high-quality, on-time results.