Regulatory Professional and Scientific Specialist
2 days ago
At ALK, we are a global pharmaceutical company specialized in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an open-minded approach, and contributing to an inspiring and fun working environment together with our colleagues.
Global Regulatory Affairs at ALK
Our team provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. You will be part of an engaged and informal team who values skill and knowledge creation.
Job Description:
- Prepare regulatory CMC documentation and handle submissions to authorities globally.
- Conduct scientific/technical writing and maintain regulatory CMC documentation for initial and life cycle submissions for strategic products.
- Have an overview of submitted and approved CMC documentation globally.
- Ensure cross-functional and external cooperation related to product life cycle activities.
- Communicate, coordinate, negotiate, and align regulatory strategies as representative for regulatory CMC in regulatory working groups and cross-functional project teams.
- Take on regulatory responsibility for compiling the CMC part of global applications and running life cycle submissions.
- Establish the right strategy for CMC documentation and submission.
- Evaluate regulatory impact for CMC changes.
- Provide regulatory guidance for various cross-functional areas.
- Monitor global regulatory requirements and conduct regulatory impact assessment related to CMC.
Required Skills and Qualifications:
You have a Master of Science, e.g., in pharmacy, engineering, or another relevant discipline, and you have experience with regulatory CMC submissions and basic knowledge of the pharmaceutical industry and GMP.
Thrive in scientific discussions with the goal of clarifying needs and identifying solutions. Be structured, and enjoy preparing clear and logically organized written material on complex scientific matters.
As there are several parallel activities and deadlines to manage in your role, your strong planning skills will also come into play. Take responsibility for getting the job done, are results-oriented, and can keep the perspective in times of increased activity.
Furthermore, you possess excellent communication and stakeholder management skills, and you master English at a high professional level, both in writing and orally.
Become a Part of Our Team:
ALK is committed to an inclusive recruitment process and equality of opportunity for all our job applicants. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply. We are looking forward to hearing from you.
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