Lead Regulatory Professional – Combination Products
ALK-Abelló
Do you have experience working with regulatory CMC submissions? Do you thrive with scientific discussions, and do you enjoy the writing of scientific documentation?The position
For our injectable Drug-Device Product (Jext®) registered globally we are looking for a regulatory colleague to manage regulatory CMC activities. You will join the Regulatory CMC, Injectable, Devices and Drops team which is part of Global Regulatory Affairs, and you will be based at our Head Office in Hørsholm. The working environment is informal and flexible, and sharing of learnings within the team is very important for us.The role is of strategic importance, and we prefer applicants with Drug-Device expertise.Your responsibilities will depend on your experience. Your daily tasks will cover preparation of regulatory CMC documentation and handling of the submissions to authorities. As there are several parallel activities and deadlines to manage your good planning skills will come into play.In this role you will:
Your qualifications
You have a Master of Science, e.g., in pharmacy, engineering, biology or other relevant discipline combined with working experience within regulatory CMC submissions preferably in a global scale. You thrive in scientific discussions with the goal of clarifying needs and identifying solutions, and you enjoy preparing clear and logically organised written material on complex scientific matters.Moreover, we expect:
Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialized in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation.
Job type:PermanentWorking hours:Full-timeWorking days:DayIndustry sector:Regulatory AffairsJob level:EmployeePosition type:Regulatory Affairs OfficerApplication deadline:15/08/2024Location:HørsholmCompany homepage:Office address:Bøge Allé 1 2970 HørsholmOffice location:ALK-Abelló A/SALK helps people living with allergy. By providing solutions that make life with allergy surprisingly simple we make a difference for many people. We build upon a strong heritage as a pioneer in allergy immunotherapy and we will continue to innovate, develop and market new products and solutions for people with allergy.
ALK is a global company with production sites in Denmark, France, Spain and the United States. We were founded in Copenhagen in 1923. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen.
We know that our employees are our most valuable asset and we believe they do their very best every day in the pursuit of new and better allergy treatments and solutions for people with allergy around the world. If you like to have influence and make a difference ALK is the right place so come join us on our exciting journey.
Hørsholm, Hovedstaden
Wed, 03 Jul 2024 05:59:57 GMT
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