BEMÆRK: Ansøgningsfristen er overskredet
Do you have a passion for support regulatory strategies and to navigate the regulatory landscape to secure successful approvals?
LEO Pharma has embarked on an ambitious journey to become the preferred dermatology care partner improving people’s lives around the world – and that is why we need you!
If you have good understanding in regulatory activities who enjoys interactions with health authorities, collaborates with different parts of the organization, and thrives working in a multi-cultural, matrix environment with many stakeholders, at a fast pace – then this job is something for you.
In Global Regulatory Affairs, you will get the opportunity to shape the future and help people with skin diseases live more fulfilling lives by advancing the standard of care.
Your role
You will provide operational and increasingly strategic global regulatory CMC support and advice to assigned product(s) and by doing so facilitate fast approvals while minimizing regulatory risk and maximizing post-approval flexibility.
- Lead Regulatory CMC related considerations for assigned projects in relevant cross functional teams based on thorough knowledge of pharmaceutical manufacturing processes.
- Prepare the regulatory strategies for assigned projects and ensure timely execution by close cross functional collaboration and alignment with relevant function in Global Regulatory Affairs and key stakeholders.
- Ensure timely communication of relevant regulatory CMC issues/risk to the Global Regulatory Team and cross functional teams.
- Responsible for coordinating the regulatory authoring and review process during regulatory CMC dossier compilation and approval process.
- Maintain the regulatory dossier during life cycle management by i.e. providing input to Change Control cases .
- Responsible for maintaining and developing Regulatory CMC understanding by i.e. understanding and applying relevant and current regulatory CMC guidances, monitoring trends in key markets and understanding the regulatory environment related to CMC for small molecules and biologics including combination products.
Your qualifications
To succeed in this role, following qualifications will be needed:
- Master or bachelor degree within science e.g. pharmaceutics, biomedicine, chemical engineer or a related field. Advanced degree preferred.
- Experience within the regulatory or equivalent area (>2 years preferred).
- Understanding and experience of drug development and life cycle management
- Understanding of pharmaceutical industry and interfaces to global regulatory affairs.
- Experience in interacting with numerous stakeholders and navigating in a cross-cultural environment.
- Prior experience in project management is highly desirable for this role
- Strategic mindset - is highly prioritized
- Strong collaboration and communication skills - is a must
Your new team
You will be part of an ambitious, highly skilled and knowledgeable Global Regulatory Affairs CMC Device area. You will report and work in close collaboration with the Head of Global Regulatory CMC, the regulatory leadership team, and relevant internal colleagues.
Contact and application
You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.
See the vacancy here and apply online:
Let’s pioneer together
At LEO Pharma, we help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration, and curiosity, and we are at the forefront of science in developing new medicines. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients.
At LEO Pharma, we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions, foster an inclusive culture, and meet the needs of the market we operate in. Therefore, we encourage you to apply for the position if you are excited about the role – even if you don’t meet every single requirement listed, you might be just the pioneer we are looking for. We believe in flexibility in all aspects - also when it comes to supporting our employees' diverse needs, hence, we offer hybrid work opportunities whenever possible.
For certain positions, LEO Pharma might complete a background check conducted by a third party.
INFORMATIONER OM STILLINGEN:
- Arbejdspladsen ligger i:
Ballerup Kommune
-Virksomheden tilbyder:
-Arbejdsgiver:
LEO PHARMA A/S, Industriparken, 2750 Ballerup
-Ansøgning:
Ansøgningsfrist: 11-01-2024; - ansøgningsfristen er overskredet
Se mere her: https://job.jobnet.dk/CV/FindWork/Details/5943633