Director of Regulatory Affairs

2 weeks ago

Tel Aviv, Tel Aviv, Israel Nasus Pharma Full time $90,000 - $120,000 per year

Nasus pharma is a clinical stage company developing powder-based Intranasal specialized product portfolio, to address acute medical conditions and public health threats.

Nasus Pharma is seeking an experienced individual to lead the Regulatory Affairs (RA) function. In this position you will act as the primary contact for cross-functional product development teams, providing regulatory guidance throughout the non-clinical and clinical development stages and recommending the most appropriate regulatory pathway.

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Responsibilities
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·      Lead communications with Health Authorities (FDA, EMA) to ensure compliance and timely submissions.

·      Prepare and review regulatory documents, including Scientific Advice, IMPD, regulatory meeting documents, and more, ensuring they meet current regulatory standards.

·      Plan and prepare CTD-based regulatory submissions in the USA and Europe (INDs, BLAs, MAAs) for new products, ensuring the timely approval of clinical studies and marketing applications.

·      Ensure completeness, accuracy, and compliance of all regulatory submissions.

·      Contribute to the planning and development of the company's strategy on assigned programs, setting regulatory goals, and ensuring clear communication with stakeholders.

·      Maintain up-to-date knowledge of regulatory guidelines, standards, and industry trends.

·      Handle routine regulatory maintenance work, such as annual reports in the US, Europe, and Israel, in compliance with local requirements.

·      Set and monitor timelines for regulatory procedures and submissions to ensure adherence to deadlines.

·      Coordinate team review of regulatory documents, and manage the organization, compilation, and submission of materials to competent.

Qualifications

·      PhD, PharmD or MSc in life sciences.

·      At least 7 years of hands-on experience in Regulatory Affairs within the pharmaceutical industry, with a preference for experience in intranasal or inhaled products.

·      Experience with clinical and non-clinical aspects of product development, as well as knowledge of manufacturing processes and GMP compliance.

·      Proven experience in authoring and reviewing regulatory submissions (e.g., CTD clinical, non-clinical, and quality modules) for global development activities leading to NDA/MAA submissions and approvals.

·      In-depth knowledge of FDA, EMA, and ICH guidelines relevant to clinical and non-clinical development and regulatory maintenance.

·      Highly motivated and independent, with a strong ability to work under pressure and meet tight deadlines.

·      Excellent communication skills and the ability to collaborate with cross-functional teams.

·      Strong attention to detail and organizational skills.

·      Fluency in English (mother-tongue proficiency or equivalent).

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