Senior Regulatory Affairs Professional
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Søborg
Do you have experience in CMC, QA, QC, RA or a related area? And can you offer a unique skill set - ideal for working with different stakeholders and regulators to make a positive impact? Do you want to be part of the team that plays a critical role in ensuring patients have access to new, safe and effective drugs? Do you have a scientific background or experience in chemistry, manufacturing and controls (CMC), quality assurance (QA), quality control (QC), regulatory affairs (RA) or in another relevant area? Then RA CMC and Device, Biotech and Rare Disease could be your next professional experience. If you want to be a part of an area where we have a high focus on work-life balance, an exciting clinical pipeline, professional development, and great career opportunities, then you could be the one we are looking for. You will have the opportunity to take the lead, make an impact, and set the strategic direction in projects of crucial importance to 's patients on a global level. Apply now for a life-changing career! About the Area and Department Regulatory Affairs CMC & Device provides the key connection between scientists and regulators to make medicines available to patients around the world by ensuring fast regulatory submissions and approvals in all global markets. The RA CMC Biotech and Rare Disease area consists of skilled, dedicated colleagues with diverse backgrounds and experience. As ’s product portfolio grows, RA CMC & Device continues to develop innovative solutions to increasingly complex CMC manufacturing strategies and regulatory requirements. There is a high focus on individualized onboarding, flexibility and empowerment in the area. Development and psychological safety are also a major focus and considered essential for the working environment. We strive for a modern way of working, including friendly colleagues, and a space to be proactive, to learn and to take the initiative to improve and make a difference. We want it to be the best place to work – not only in words, but we walk the talk in this area. The Position As a member of the RA CMC & Device, Biotech and Rare Disease team, you will have the opportunity to work across the various phases of clinical development, including early and late phase clinical studies, planning and executing meetings with the health authorities, and submitting marketing authorization applications. You will be the voice of RA CMC & Device, Biotech and Rare Disease and you will turn your knowledge and experience into dynamic regulatory strategies based on current regulatory requirements. You will be in the centre of project planning and execution – responsible for planning, coordinating, and reviewing regulatory documentation related to the drug. Documentation includes supporting the preparation of applicable sections of submission packages, responses to agency questions and agency meeting packages. Additional aspects of the role include: Applying regulatory intelligence to develop robust regulatory strategies. Identifying as well as improving regulatory CMC practices, processes and approaches related to regulatory CMC documentation and strategies. Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office and on-site work. Qualifications You come with a scientific background and mindset, which you have acquired through your extensive experience from pharmaceutical operations – manufacturing, product supply, process development, CMC development, analytics, quality assurance and other related areas. The ideal candidate should have: Master's degree and/or PhD in a relevant field At least 5 years of relevant experience within the pharmaceutical industry High proficiency in English - written as well as spoken Great communication skills as all work takes place in multidisciplinary project groups You are a dedicated team player, you find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness and integrity. Furthermore, you thrive in the challenging reality of international communication across time zones and cultures. Visit our Regulatory Affairs Careers webpages For more information about job content and qualifications, please visit the Regulatory Affairs Careers webpages at Contact For more information regarding the role, you are welcome to contact Dorte Lunøe (+or Nermin Ipek (+). Deadline for Application April 15th 2024. Please note that applications will be reviewed continuously, and we will be conducting interviews on an ongoing basis. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 18.3.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Søborg
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| 31. marts 2024 | 17 |
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