Regulatory Affairs Professional

2 days ago

belgaum, India beBeeRegulatory Full time

Job OverviewWe are seeking a skilled Regulatory Affairs Specialist to join our team. This role involves managing global health authority submissions, conducting dossier gap analysis, and ensuring the accuracy of CMC, clinical, non-clinical, and administrative documentation.Key Responsibilities:Manage regulatory submissions for multiple products across various countries.Utilize project management tools to track project milestones, timelines, and deliverables.Foster seamless communication between central regulatory teams and client stakeholders.Job DescriptionThis position requires strong analytical and problem-solving skills, with the ability to work effectively in a fast-paced environment. The successful candidate will have excellent communication and interpersonal skills, with the capacity to build strong relationships with internal and external stakeholders.RequirementsBachelor's degree in a relevant field such as life sciences, pharmacy, or a related discipline.Minimum 3 years of experience in regulatory affairs, preferably in a pharmaceutical industry setting.Strong knowledge of regulatory requirements and guidelines, including ICH, FDA, EMA, and WHO regulations.Proficiency in MS Office, particularly Excel, Word, and PowerPoint.Preferred Qualifications:MSc or Ph.D. in a relevant field.Professional certifications such as RAC, QP, or similar.Experience working in a multinational environment.BenefitsWe offer a competitive salary package, comprehensive benefits, and opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, please submit your application.

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