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

• providing regulatory expertise and input to team recommendations to facilitate successful product development globally;
• 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;
• 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 serve as a 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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