Senior Regulatory Compliance Specialist

4 days ago

kannur, India beBeeRegulatoryAffairs Full time

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Associate to join our team. The successful candidate will be responsible for developing and maintaining a thorough understanding of various regulatory frameworks and guidelines, including ICH, US FDA, EMA, and other regional regulations.The ideal candidate will have excellent collaboration skills, with the ability to work effectively with cross-functional teams to prepare and submit high-quality regulatory documents, ensuring compliance with international standards and domestic regulations.ResponsibilitiesDevelop and maintain a comprehensive understanding of regulatory frameworks and guidelines.Collaborate with cross-functional teams to prepare and submit regulatory documents.Prepare and review Marketing Authorization Applications & Variations for filing in major markets.Key Skills and QualificationsThe following skills and qualifications are required:Strong knowledge of regulatory frameworks and guidelines.Excellent communication and problem-solving skills.Able to work independently and collaboratively.Familiarity with regulatory aspects of CMC, QP, and related procedures.What We OfferThis role offers the opportunity to work on challenging projects and develop your skills and expertise in regulatory affairs.OthersRegulatory Affairs Associate will be responsible for staying up-to-date with regulatory changes and developments, and contributing to the development of our company's regulatory strategy.

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