Regulatory CMC Specialist
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Ballerup
Do you want an exciting job within the regulatory CMC area?
LEO Pharma has set the highly ambitious goal to become the world’s preferred dermatology care partner. To fulfil this vision, we invest massively in development at all levels and enter into new business areas e.g. biologic treatments. As a member of RA CMC you will get the opportunity to work with LEO Pharma’s products approved world-wide.
Key Responsibilities
As Regulatory Affairs CMC Specialist, you will be working with the life-cycle management of the quality documentation of products in LEO Pharma’s portfolio. You will work with approved drug products and drug substances. You will perform regulatory assessment of change control cases, participate in planning variation applications for different types of CMC changes and prepare regulatory strategies for the variation applications. You will also support renewal applications. You will work in RA product teams where you, in close cooperation with other Regulatory Affairs colleagues, will plan and project-manage CMC related aspects regarding submissions of variations. You will be part of a cross-functional team, which have the responsibility to maintain the quality documentation and handle CMC-related issues for the drug products and drug substances.
You will also take part in the general activities in the department, including improving and implementing integrated regulatory business processes and share new Regulatory Intelligence knowledge.
Experience & Qualifications
We expect you to have:
A relevant scientific degree; 2-5 years of experience from Regulatory Affairs preferable within CMC life-cycle management of approved products; knowledge of regulatory requirements within EU and a broad knowledge of regulatory requirements in other markets and countries outside EU; clear focus on agreed objectives, even when working with tight deadlines.
Furthermore, you are:
A strong communicator, passionate and enthusiastic in your way of working, a professional with positive and proactive influencing skills with the ability to take ownership, a strong and proactive team player who thrives on working in an international environment, a professional who can motivate others to adapt to new processes and understand how to build efficient working relationships with both internal and external stakeholders.
About Global Regulatory Affairs
In GRA we are responsible for global regulatory activities from early development throughout the life-cycle of our products in more than 100 countries world-wide. We work closely together with our colleagues across functions and with our affiliates, area offices, partners and consultants.
LEO Pharma has set the highly ambitious goal to become the world’s preferred dermatology care partner. To fulfil this vision, we invest massively in development at all levels and enter into new business areas e.g. biologic treatments. As a member of RA CMC you will get the opportunity to work with LEO Pharma’s products approved world-wide.
Key Responsibilities
As Regulatory Affairs CMC Specialist, you will be working with the life-cycle management of the quality documentation of products in LEO Pharma’s portfolio. You will work with approved drug products and drug substances. You will perform regulatory assessment of change control cases, participate in planning variation applications for different types of CMC changes and prepare regulatory strategies for the variation applications. You will also support renewal applications. You will work in RA product teams where you, in close cooperation with other Regulatory Affairs colleagues, will plan and project-manage CMC related aspects regarding submissions of variations. You will be part of a cross-functional team, which have the responsibility to maintain the quality documentation and handle CMC-related issues for the drug products and drug substances.
You will also take part in the general activities in the department, including improving and implementing integrated regulatory business processes and share new Regulatory Intelligence knowledge.
Experience & Qualifications
We expect you to have:
Furthermore, you are:
A strong communicator, passionate and enthusiastic in your way of working, a professional with positive and proactive influencing skills with the ability to take ownership, a strong and proactive team player who thrives on working in an international environment, a professional who can motivate others to adapt to new processes and understand how to build efficient working relationships with both internal and external stakeholders.
About Global Regulatory Affairs
In GRA we are responsible for global regulatory activities from early development throughout the life-cycle of our products in more than 100 countries world-wide. We work closely together with our colleagues across functions and with our affiliates, area offices, partners and consultants.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 21.1.2020, 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.
- Øvrige
- Ballerup
- Lørdag den 15. februar 2020
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