Informacje o stanowisku

Senior Manager Regulatory Affairs (CMC) Warszawa

Step into a pivotal role as Manager, Regulatory Affairs and contribute to the global development and lifecycle management of groundbreaking pharmaceutical products. As a key member of the team, you will lead the development and execution of global CMC regulatory strategies, ensure compliance with regulatory requirements, and represent Global CMC Regulatory Affairs in cross-functional and external collaborations. This is an exciting opportunity to shape global submission plans, drive continuous improvement, and influence policy and practices within a dynamic and innovative environment.

What we expect

• BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 10+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent.
• Proficiency in English (min. C1).
• Demonstrated ability to communicate regulatory requirements.
• Solid understanding of biology, chemistry and/or engineering relevant to the pharmaceutical industry.
• Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy.
• Strong attention to detail with high-level verbal and written communication skills.
• Communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams.
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.
• Experience leading interactions with Health Authorities under supervision of a senior member of the CMC RA staff.
• Strong knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.
• Good understanding of competitors in the area and what they are doing in early/late development.

What we offer

• Hybrid model of work for flexibility and convenience.
• Company car to support your mobility needs.
• Comprehensive private medical care and life insurance for you and your family.
• A robust company pension plan to secure your future.
• Reimbursement for sports activities and access to well-being programs to promote a healthy lifestyle.
• Annual bonus recognizing your contributions and achievements.
• Beneficial leave policies to support your personal and professional needs.

Participates as the Regulatory CMC Lead on CMC/VST Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally. Actively participates on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements and commitments. Develop and execute global CMC regulatory strategy. Leads the preparation of regulatory dossiers for submission to Health Authorities. Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed. May lead selected initiatives within CMC RA / GRA. Participates in and conducts due diligence/licensing evaluations as needed. May provide oversight of assigned staff. Drives a culture of continuous improvement and communicates critical issues to Management. May represent CMC RA on Cross Functional Teams. May serve as a SPOC/SME on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise. Ensures the CMC development and commercial product regulatory strategy meets global regulatory requirements. Assures connectivity to the overall global regulatory strategy through partnership and communication with other departments. Refines regulatory strategies as new data become available. Develop and update contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope. Effectively and tactfully communicates with health authorities. Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle. Provides accurate regulatory assessments of chemistry, manufacturing and control changes to teams/projects and executes regulatory planning and implementation.

Warszawa - Oferty pracy w okolicznych lokalizacjach