Work Schedule

Environmental Conditions

Job Description

Join Us as a Regulatory Affairs Manager – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to provide technical and project leadership over a region(s). As a Regulatory Affairs Manager, you'll offer innovative solutions, including regulatory affairs expertise and client interface, to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. You will provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements.

Scientist CMC analytical development occupies a supporting role in Chemistry, Manufacturing and Controls (CMC) team for our Client therapeutic antibodies and their life cycle management following commercialization.

What You’ll Do:
• Follow up on the execution of agreed commercial supply plan for outsourced QC testing in close collaboration with CMC commercial team and Global supply team; receival of external CoA and CoC’s, author the internal specification documents (JOS, Specifications and CoA’s) for the bulk drug substance and drug product
• Close follow up of actions for change controls, deviations, OOS investigations related to QC activities at external vendors in close collaboration with the DS and DP manufacturing and QA team; supports investigations for OOE/OOT release and stability results including root cause investigations and impact assessments on the process performance capabilities; be part of the argenx investigation team during interactions with external CMO’s providing expert input regarding QC activities
• Close follow up on stock levels and distribution of critical reagents and reference standard inventories; follow up on shipments from the main stock to the working stocks at the different QC labs; support the activities to replenish critical reagents in due time and in accordance to the regulatory submissions. Follow up of the reference standard trending and stability programs; author retest date statements
• Maintain the complete data repository of product quality via control charts of the analytical critical quality attributes, as part of process performance evaluation
• Follow up on annual stability trending within the approved shelf-life;
• Follow up on the analytical method life cycle, possible transfers, protocols and reports; and analytical method performance trending across the multiple QC testing sites
• As a member of the CMC commercial team contribute to technical and strategic CMC discussions; review CMC module 3 sections in support of global submission plans.

Education and Experience Requirements:
Master in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within pharmaceutical/biotechnology sciences;
• Strong technical expertise in the field of biological drug substance and drug product manufacturing, analytical method development and validation; process validation and good understanding of statistics;
• Fluent in English, written and spoken;

Knowledge, Skills and Abilities:
• Thorough knowledge and experience with GMP and in depth knowledge of ICH and GMP regulations;
• Works independently within the scope of his/her assigned field and supports others;
• Keep abreast with relevant scientific and/or technical developments;
• Ability to go into detail whilst keeping the view on the overall project goal;
• Strong technical expertise combined with good project management skills and ability to communicate effectively with internal and external stakeholders;
• Flexible attitude, capable of picking up the tasks that require attention;
• Quality conscious attitude;
• Well organized;
• Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines;
• Team player; able to build effective relationships with internal and external stakeholders

Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.