Regulatory Affairs Specialist (f/m/d)

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Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Cytiva one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines new medicines and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us working on challenges that truly matter with people that care for each other our customers and their patients. Take your next step to an altogether life-changing career.

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The Regulatory Affairs Specialist for Cytiva is responsible for supporting submission of animal-derived products and cell culture media responsibilities that drive significant impact to the organization.

This position is part of the Global Regulatory Compliance (GRC) Team and will be on-site in Krakow Poland. At Cytiva our vision is to advance future therapeutics from discovery to delivery.

In this role you will have the opportunity to:

• Prepare review and submit regulatory filings and submissions to relevant authorities ensuring adherence to all applicable regulations and guidelines.

• Monitor and influence regulations related to animal-derived products by participating in working groups and industry associations.

• Support the development and implementation of regulatory strategies for new products within the Cytiva portfolio ensuring timely market access.

• Review change requests to ensure that compliance requirements are met and maintained.

• Provide regulatory guidance for animal origin products in the supply chain (e.g. imports exports pre-notifications and health-certificates) as well as support cross-functional activities.

The essential requirements of the job include:

• Minimum of 3-5 years experience in regulatory affairs preferably with focus on animal-derived products and cell culture media.

• In-depth knowledge of regulatory requirements and guidelines for animal-derived products including GMP FDA EMA and other relevant standards backed up by ability to develop and implement effective regulatory strategies.

• Excellent communication and interpersonal skills with ability to work effectively in cross-functional teams.

• Detail-oriented with strong organizational / analytical / problem solving skills as well as project management abilities.

• Proficiency in regulatory submission software and other relevant tools.

• English (written and spoken) is mandatory German would be an asset.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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