Regulatory Affairs Associate

57529 - Regulatory Affairs Associate - Maternity leave replacement

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

To lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirements.

How you’ll spend your day

• 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 for all relevant markets
• Proactively collaborates with the Regulatory Specialist team members, which support the submission or answer service requests
• Prepare a DMF specific high level gap analysis report and proactively communicate any risk to the relevant departments. Follow up on the gaps' solving during the review period
• Respond to deficiency letters and coordinate related activities
• Coordinating pre-launch activities from RA perspective
• Manages the regulatory aspects and related tasks of the assigned commercial APIs
• Evaluate change requests and address the required submission per market to support the requested change. Follow through the submission
• Maintain up to date the DMFs according to the required regulation of updating per market.
• Support customers regarding Service Requests, giving relevant professional information in the shortest of time
• Continue learning of regulatory guidance, SOPs and work processes

Your experience and qualifications

• High degree in relevant field, e.g. chemistry/biochemistry/biology or biotechnology
• High service approach to internal & external customers
• Good Leadership and communication skills
• English good professional level, both in writing and speaking