Global Regulatory Strategy Specialist
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* We are seeking an experienced and forward-thinking Global Regulatory Strategy Specialist to join our team. As a key member of the regulatory department, you will be responsible for developing and implementing cutting-edge global strategic regulatory strategies for assigned projects in the Therapeutic Area of Mental Health, Eye Health & Emerging Areas.
* You will work closely with cross-functional teams to assess regulatory risks, propose innovative solutions, and ensure that regulatory considerations are incorporated timely and comprehensively in the decision-making process.
* The ideal candidate will have a strong background in Regulatory Affairs, with experience in multiple regions including the US and/or EU. You will possess a proven track record of developing and implementing successful regulatory strategies, ideally with preparation of IND, (s)BLA/(s)NDA and/or MAA, Health Authority meeting briefing documents and negotiating with Health Authority(ies) in a major market (e.g. US, EU).
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About this Role:
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* This is a pivotal role where you will lead the development and implementation of global strategic regulatory strategies for assigned projects, ensuring compliance with regulatory requirements and industry standards.
* You will provide expert advice on regulatory matters, collaborating closely with stakeholders to align regulatory strategies with business objectives.
* The position can be filled in Germany or the US, offering flexibility and opportunities for growth within the company.
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Your Responsibilities:
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* Develop and implement global strategic regulatory strategies for assigned projects, ensuring compliance with regulatory requirements and industry standards.
* Provide expert advice on regulatory matters, collaborating closely with stakeholders to align regulatory strategies with business objectives.
* Assess regulatory risks and propose innovative solutions to drive project goals and maintain the highest standards of professionalism, ethics, and regulatory compliance.
* Collaborate with cross-functional teams to ensure that regulatory considerations are incorporated timely and comprehensively in the decision-making process.
* Mentor and support team members to foster a culture of excellence and continuous learning within the regulatory department.
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Your Qualifications:
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* High level of education in pharmacy, life sciences, or chemistry, ideally holding a Master's or Doctoral Degree.
* In-depth knowledge of Regulatory Affairs across multiple regions, including the US and/or EU.
* Proven track record of developing and implementing successful regulatory strategies, ideally with preparation of IND, (s)BLA/(s)NDA and/or MAA, Health Authority meeting briefing documents and negotiating with Health Authority(ies) in a major market (e.g. US, EU).
* Experience in COA strategy development, including COA dossiers, will be considered beneficial.
* Strong critical thinking and strategic mindset, with the ability to anticipate both opportunities and challenges in execution.
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About Our Company:
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We are a dynamic and innovative organization dedicated to improving human and animal health through groundbreaking therapies. With a long-term perspective and a commitment to diversity, equity, and inclusion, we offer a collaborative and inclusive work environment that fosters growth and development for all employees.
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