Informacje o stanowisku

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 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 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.

Employment agency entry number 47

this job offer is intended for people over 18 years of age

What we offer

• hybrid model of workfor flexibility and convenience,
• company carto support your mobility needs,
• comprehensiveprivate medical careandlife insurancefor you and your family,
• a robustcompany pension planto secure your future,
• reimbursement for sports activitiesand access towell-being programsto promote a healthy lifestyle,
• annual bonusrecognizing your contributions and achievements,
• beneficial leave policies to support your personal and professional needs.

Your tasks

• 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 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.

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