Senior Associate Regulatory Affairs

Job description

Career CategoryRegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. SENIOR ASSOCIATE REGULATORY AFFAIRS WHAT YOU WILL DO In this vital role you will assist in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, and Regulatory Affairs processes and deliverables for the ELI markets Egypt, Jordan, Iraq and Lebanon. Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and requirements Manufacturing site registration and license maintenance Responsible for coordinating with the International regulatory team to ensure right first-time dossiers are provided Coordinate and respond to the requests by authorities during the evaluation process and check the correct handling of deficiency letter within a specific timeframe in order not to delay MOH approvals Establish effective communication and continuous follow-up with the external agencies & distributors to ensure timely submissions and approvals of all company’s applications Monitoring of emerging guidelines and changes affecting business and communication to relevant internal customers Providing guidance on the approval processes to internal stakeholders within the region and providing regulatory input for launch planning Maintenance of all lifecycle activities/ Product renewal license details by accurately preparing filling submissions and approval within the preset global timelines -accountable for overall accuracy and compliance Ensure alignment of regulatory objectives with regional / global regulatory objectives and commercial plans Accountable for solving all supply issues related to regulatory activities. To provide regulatory intelligence Ensure compliance with company's SOPs and working practices for Good Regulatory Practice Management of documentation archiving and record keeping according to SOP and local legislation Contact for agency interactions for portfolio of products and coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies Collate, distribute, exchange and archive regulatory information with colleagues across the business Participate in regulatory and affiliate process improvements initiatives Review promotion and non-promotion materials to ensure compliance with local license, company procedures and Code of Practice BE PART OF OUR TEAM Reporting to the Regulatory Affairs Manager for ELI, you would be joining a team of regulatory professionals passionate about delivering the best outcomes for our medicines to patients. WHAT WE EXPECT OF YOU We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills: Pharmacy Bachelor’s degree 2-3 years of directly related experience in regulatory affairs (ELI markets) Knowledge and awareness of the relevant regulatory guidelines and legislation for ELI markets Strong communication skills both verbal and written Organizational skills & developing regulatory project management skills Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status. .