DRA

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.

To handle all kind of lab instruments and experience to perform AMV and Documentation EM Monitoring, Water testing. Trend preparation, Microbial Testing, SOP and Protocol and other micro related activity

Create and review regulatory documentation for Drug, Device and Combination product renewals and other life cycle maintenance-related submissions. Track status and progress of regulatory documentation.

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.

The job requires review of documents related to DMF submission against predefined checklists and submission to various agencies globally.  Should keep the all the regulatory database up to date. Candidate must possess do it right the first-time approach with proven track record. 

Awareness of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries. Excellent written and spoken communication skills in English

As an Associate Regulatory Affairs Director I, you will be a key contributor to regulatory submission strategy, identifying submission risks and opportunities. You will lead regulatory applications and manage procedures through approval.

Seasoned experience in handling of various EU procedure like DCP, MRP, National. National phase handling for EU procedures. Post approval variation compilation and filling to various EU agencies