استخدام Regulatory Affairs Expert

شرح موقعیت شغلی

• Stay abreast of evolving regulatory legislation and guidelines (ICH/EMA/FDA/WHO) to ensure compliance.Managing the registration process: Prepare and manage submissions/dossiers for regulatory bodies, liaising with health authorities for efficient registration and maintenance.
• Scientific and technical proficiency: Analyze scientific and legal documents, evaluate data, and oversee product studies/clinical trials.
• Communication and collaboration: Provide expert advice to internal departments, negotiate with regulatory authorities, and possess strong written and oral communication skills.
• Project management excellence: Organize and manage complex tasks, prioritize effectively, and meet strict deadlines while maintaining the highest quality standards.

• Scientific and legal acumen: Demonstrate a solid understanding of both legal and scientific concepts within the biosimilar industry.
• Proven track record: Minimum of 1 year of experience in a related regulatory affairs role within the pharmaceutical industry.
• Sharp mind and strong work ethic: Possess excellent analytical skills, the ability to learn quickly, and thrive in a fast-paced environment.
• Organizational mastermind: Excel at project management, prioritize effectively, and maintain meticulous attention to detail.
• Effective communicator: Demonstrate strong written and oral communication skills, including negotiation abilities.
• Team player: Collaborate effectively with internal and external stakeholders.
• Fluency in English: Written, spoken, and listening comprehension are essential. Additional language skills are a plus!

مهارت‌های مورد نیاز

• شیمی دارویی
• کنترل فرایند

حداقل سابقه کار

• مهم نیست

جنسیت

• مهم نیست

وضعیت نظام وظیفه

• معافیت دائم پایان خدمت

مشاهده آگهی‌های استخدام مشابه