Responsibilities:
- 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.
- Lead communications with Health Authorities (EMA, FDA) 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.
- Collect, collate, and evaluate scientific and technical data from the relevant product development teams (non-clinical, clinical, medical).
- Plan and prepare CTD-based regulatory submissions in Europe and the USA (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.
- Provide global support to marketing and operations teams across various markets.
- 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 authorities across the EU, FDA, and other regions.
- Identify, assess, and mitigate regulatory risks and project issues, offering solutions to the project teams.
Requirements:
- PhD, PharmD, MSc in life sciences, or a pharmacy degree.
- At least 5 years of hands-on experience in Regulatory Affairs within the pharmaceutical industry, with a preference for experience in biological products and innovative pharmaceutical companies.
- 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 BLA/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).