דרושים Regulatory Affairs Specialist

Regulatory Affairs representative for business unit Programs and assists with regulatory matters such as labeling, marketing, technical documents, and regulatory design change assessment required in the Development Life Cycle. Support...

Prepare and maintain electronic submissions (eCTD) of DMFs, via a publishing system, according to industry guidelines. Submission of DMFs, prepared by RA team, to authorities according to relevant guidelines. Routine...

Provide Regulatory read on product design and process changes to cross- functional teams. Act as a core member on manufacturing and remediation teams, providing regulatory feedback and guidance throughout the...

Prepare and maintain electronic submissions (eCTD) of DMFs, via a publishing system, according to industry guidelines. Submission of DMFs, prepared by RA team, to authorities according to relevant guidelines. Routine...

Supporting regulatory planning for new product introductions and product changes, and assist in maintaining, regulatory compliance. Product submissions, global registrations and communication with authorities. Managing compliance to global regulations, standards...

Planning & Coordination:Plan and delegate functional activities, ensuring resources are available.Prioritize and coordinate daily tasks of assigned staff and time-critical regulatory activities. Plan and delegate functional activities, ensuring resources are...

Support the life cycle management of APIs from RA perspective. Review and approve ROS, specification and analytical control when required. Coordinate DMF preparation and related activities for On Time Submissions...