Global Regulatory Compliance Specialist

1 week ago

nadiad, India beBeeRegulatory Full time

Regulatory Affairs ProfessionalThis key role is centered around overseeing regulatory submissions for a diverse range of products across multiple countries.Key responsibilities include:Preparing and submitting regulatory dossiers to global health authorities, involving dossier conversion and preparation in various formats.Conducting thorough dossier gap analysis and managing the end-to-end process for lifecycle submissions including ANDA, NDA, BLA, MAA, and other submissions.Facilitating collaboration with cross-functional teams and ensuring seamless data collation to guarantee successful global submissions.Key qualifications include:Expertise in understanding global dossier formats, submission pathways, and lifecycle management.Strong communication and coordination skills with the ability to work effectively across functional boundaries.Able to manage complex, multi-country regulatory portfolios with ease.The ideal candidate will have 8-10 years of experience in Regulatory Affairs, with a deep command over CMC, clinical, non-clinical, and administrative documentation.Must possess excellent organizational skills, be proactive, and able to prioritize tasks efficiently.We are seeking an individual who can excel in this critical role and contribute significantly to our team's success.

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