Regulatory CMC Lead (f/m/d)

Your responsibilities

• Formulate, lead, and drive global CMC/regulatory strategy, regulatory submissions, and health authority interactions for biosimilars and innovative products in a matrix organization.
• Represent RegCMC in interdisciplinary project teams and partner with Technical Operations, Manufacturing Science and Technology (MS&T), Quality Control,
• Quality Compliance, Quality Assurance, and Technical Research & Development functions.
• Provide strategic regCMC and medical device input to development projects.
• Identify required documentation for global submissions, negotiate the delivery of approved technical source documents, and ensure quality and timeliness according to project timelines.
• Prepare, support, and/or lead regCMC and medical device-related sections of regulatory submissions and correspondence (including briefing books, CTAs, INDs, MAAs, BLAs).
• Support evaluation of change requests and quality agreements with regards to regCMC and medical device-related topics.
• Support regulatory agency inspections and respond to health authority questions.
• Monitor changes in regulatory guidelines and competitor programs affecting regulatory strategy, submissions, and approvals.
• Provide regulatory guidance to project teams on CMC-related development topics and site registration requirements.
• Guide interdisciplinary teams in preparing high-quality documents for regulatory submissions.
• Act as site facilitator for regCMC-related topics.
• Drive preparation of CMC-related sections of CTAs/INDs/MAAs/BLAs according to project timelines.
• Maintain and archive regulatory documentation, assure correct formatting according to global requirements.
• Lead the timely preparation of responses and participate in health authority meetings (scientific advice, pre-submission meetings).
• Prepare and communicate regulatory risk assessments, contingency plans, and lessons learned.
• Escalate regulatory issues impacting submission timelines to the leadership team.
• Coach and mentor less experienced team members within the Regulatory Affairs department.
• Actively participate in RA infrastructure (working instructions, cross-functional SOPs) and capability building.
• Interact with external license partners, service providers, and CMOs.
• Lead cross-functional matrix teams for regulatory submissions and ensure timely and successful implementation of regulatory plans.

Our expectations

• MSc or PhD in biotechnology, biochemistry, biology, or equivalent.
• Over 7 years of industry experience in regCMC area, with a focus on biologics/monoclonal antibodies (ideally biosimilars), covering both development and commercial products.
• Experience working with CMOs, CROs, and external consultants on manufacturing changes, clinical trial documentation, health authority inspections, and dossier amendments.
• Practical experience in eCTD publishing and dossier compilation.
• Deep knowledge of relevant legislation and international guidelines, focusing on EU and US procedural aspects of regulatory submissions (EMA and FDA).
• Proven track record in the preparation of regCMC-related aspects of clinical trial documentation/INDs and ideally MAAs/BLAs.
• Excellent planning, communication, documentation, and organizational skills.
• Hands-on approach, ability to work successfully in cross-functional teams within a matrix organization.
• Strong collaboration and decision-making orientation, ability to influence and drive decisions.
• Effective multitasking and project management under time and workload pressure.
• High attention to detail, commitment to follow projects through to completion.
• Professional proficiency in English (written and spoken); Polish is an advantage.

We offer

• Opportunity to lead strategic regulatory projects for biosimilars and innovative products
• Work in a dynamic, international environment with experienced professionals
• Involvement in global submissions and interactions with health authorities
• Professional development and advancement in Regulatory Affairs
• Collaborative culture and mentoring opportunities
• Participation in projects that shape the biopharmaceutical industry

At Rezon Bio, we believe in diversity and equality. Our recruitment process is conducted in a fully transparent manner and with respect for non-discrimination principles – regardless of gender, age, orientation, gender identity, or other individual characteristics. We encourage all individuals who meet the requirements to apply, including women, men, and non-binary persons. What matters most to us is your experience, skills, and passion for achieving goals together!