Regulatory affairs

HPLC, GC method development for OSD & API having exposure to regulated, Semi Regulated and India markets including Complex generic, F2F, Topical and Dermaceuticals, Peptides, Oncology.

Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market. Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action. Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions

Candidates with experience in Formulation QA RA, Analytical, Formulation R&D, and interested in advancing their career in RA ROW, are encouraged to apply.

Plans and coordinates activities to ensure regulatory lifecycle management activities and approvals are achieved by the Local Operating Company in a timely manner for all globally approved products.

Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management. Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities

To file amendments and deficiency response within timelines with go getter approach. The job requires review of documents related to DMF submission against predefined checklists and submission to various agencies globally.

eCTD Compilation, validation, and submission to Health Canada and US through ESG gateway for New Submission ANDS, NDS, Deficiencies response Clarifax, SDN, NOD, NON, Supplements submissions

The Regulatory Affairs Manager II is fully proficient in applying established standards and performs regulatory affairs management for moderately to highly complex international market submissions in all regions with minimal coaching. They are expected to facilitate strategic input, provide proactive contribution to submission planning, identify areas for continuous improvement, and lead cross-functional activities. They participate in the continuous improvement of processes and tools, systems.