Regulatory Affairs Manager

pIf 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 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 as: /pbrIs dit de functie die u zoekt? Zo ja, lees dan verder voor meer details en zorg ervoor dat u vandaag nog solliciteert.brREGULATORY AFFAIRS MANAGERbrpAt Amgen Breda medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 42 different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines. /pbrpbLIVE /b /pbrWhat you will dobrpIn this vital role you will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans. /pbrpThe primary responsibilities of this role are to support the planning and execution of the site-specific aspects of the preparation of CMC sections for new marketing applications, and post-market supplements and preparation CMC sections of annual reports of minor changes for specific products, acts as key Regulatory Affairs (RA)-CMC representative for managing change control, deviations and serve as the point of contact for communications with business partners and global regulatory authorities for requests related to the site. /pbrpSpecific responsibilities include but are not limited to: /pbrullibr/liliSupport the develop and implementation of regulatory strategies as they relate to changes at the site.br/liliLead submission process for site initiativesbr/liliProvide strategic expertise regarding regulatory requirements for manufacturing related projects.br/liliCollaborate with Regulatory Authorities as appropriate and in coordination with Global and International representatives.br/liliSupport regulatory authority inspections as required by Site Quality Compliance.br/liliServe as RA - CMC representative on Cross Functional Teams.br/liliLead or collaborate in the creation site related regulatory components for global submissions.br/liliSupport the generation of facility and GMP related documents to be used in product registrations activities.br/liliReview and approve regulatory documents.br/liliReview and assess the regulatory impact of proposed manufacturing related changes, deviations and other GMP related documents.br/liliMaintain facility related files.br/liliDevelop and maintain regulatory awareness through meetings, conferences and regulatory contacts.br/li /ulbrWINbrpWhat we expect of you /pbrpWe are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs Mgr professional we seek is a strong leader with these qualifications. /pbrullibr/liliDoctorate degree / Master’s degree and 3 years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharmaceutical/Biotech industrybr/liliOR Bachelor’s degree and at least 5 years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharmaceutical/Biotech industrybr/liliEducational background in Biology, Biotechnology, Microbiology or Chemistrybr/liliExperience managing change control and regulatory submissionsbr/liliStrong oral and written communication skills in English and Dutchbr/liliStrong negotiating and leadership skillsbr/liliExperience managing project timelines is desirablebr/liliProficiency working with teams at different levels and company locationsbr/liliAble to operate in a fast paced, dynamic environmentbr/li /ulbrTHRIVEbrpWhat you can expect of us /pbrpAs 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. Therefore, Amgen is regularly recognized as a Best Place To Work ©. /pbrullibr/liliVast opportunities to learn and move up and across our global organization.br/liliDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.br/liliGenerous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance. xgiwjmb br/liliFocus on vitality with an on-site gym, vitality program and a restaurant with healthy food.br/li /ulbr