Regulatory Expert
4 days ago
Are you a motivated and detail-oriented professional looking for a new challenge in regulatory affairs? We are seeking an experienced Regulatory Professional to join our team at ALK, a global pharmaceutical company specializing in allergy immunotherapy.
About the RoleThis is an exciting opportunity to work in a dynamic and collaborative environment where you will be responsible for preparing regulatory CMC documentation and handling submissions to authorities globally. You will also contribute to scientific/technical writing and maintaining regulatory CMC documentation for initial and life cycle submissions.
As a key member of our Global Regulatory Affairs team, you will have a unique opportunity to shape our regulatory strategies and ensure compliance with global regulations. Your expertise will help us to develop innovative products that make a real difference in people's lives.
About ALKALK is a leader in the development and production of allergy treatments. We offer a comprehensive range of products that cater to the needs of patients worldwide. Our mission is to provide high-quality solutions that improve the lives of people suffering from allergies.
We believe in creating a positive and inclusive work environment that encourages collaboration, innovation, and growth. As part of our team, you will have access to training and development opportunities that will help you to achieve your career goals.
Key Responsibilities- Preparation of regulatory CMC documentation and handling submissions to authorities globally.
- Scientific/technical writing and maintenance of regulatory CMC documentation for initial and life cycle submissions.
- Overseeing submitted and approved CMC documentation globally.
- Cross-functional and external cooperation related to product life cycle activities.
- Representing regulatory CMC in regulatory working groups and cross-functional project teams.
To succeed in this role, you should have a Master of Science in a relevant discipline (e.g., pharmacy, engineering) and experience with regulatory CMC submissions. You should also have basic knowledge of the pharmaceutical industry and GMP.
You must be able to thrive in scientific discussions, preparing clear and logically organized written material on complex scientific matters. Strong planning skills are essential to manage parallel activities and deadlines effectively. You should take responsibility for getting the job done, be results-oriented, and maintain a perspective in times of increased activity.
BenefitsWe offer a competitive salary of $85,000 per annum, plus benefits such as health insurance, pension plan, and paid time off. Our office is located in Hørsholm, Denmark, but we also offer remote work options to ensure a healthy work-life balance.
About the TeamYou will join a team of 11 professionals who value skill and knowledge creation. We are driven by professionalism, integrity, an open-minded approach, and contributing to an inspiring and fun working environment together with our colleagues. Our team forms part of Global Regulatory Affairs and works closely with other departments to ensure seamless communication and collaboration.
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