Global Regulatory Affairs Senior Specialist - CMC
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Ballerup
Make your mark and set the direction – as part of RA CMC
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred medical dermatology care partner. To fulfil this vision, we invest massively in development at all levels and enter new business areas e.g. oral treatments. As a member of RA CMC, you will get the opportunity to work with LEO Pharma’s products approved world-wide and bring innovative products to patients where there is still an unmet need for effective therapy.
As part of RA CMC Small Molecules, you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
As Regulatory Specialist you will be responsible for the project plan and project execution, provide and drive CMC regulatory input for the project strategy, interact with internal and external stakeholders (e.g. Health Authorities) and represent Regulatory Affairs in relevant cross organizational project teams. Here, you ensure regulatory deliverables within CMC according to agreed timelines and quality. As senior RA expert you will assume the role of the challenger who makes an impact, seeks solutions and drive discussions within RA CMC.
You will be part of the global regulatory teams being responsible for leading the CMC related discussions and regulatory activities for assigned projects. As a Regulatory Specialist, you will be overall responsible for the CMC deliverable ensuring submission and approval of clinical trial applications, for driving and coordinating preparation of or part of meeting packages to Health Authorities when related to CMC specific issues, prepare and conduct/attend Health Authority interactions and as part of the team for ensuring regulatory submissions and approvals. You will interact with subject matter experts within the CMC organization and collaborate and facilitate discussions with regulatory input obtained via your knowledge, peer discussions or engagement with the regulators. All in all, with the responsibility you will have a lot of influence and impact on the way we reach our goals.
You will report to the Senior Manager of RA CMC Small Molecules and take active part in department related activities, including improvement projects across RA.
Your qualifications
We expect you to have:
As a person you are well organized and can approach and engage in challenging situations with solid problem-solving capabilities. You show a winning attitude, never let the goal out of sight and never lose your strategic focus. You are a skilled communicator and understand how to build efficient working relationships with both internal and external stakeholders. Finally, you are comfortable using fluent written and spoken English on a daily basis.
Your new team
RA CMC consist of three departments: Small Molecules, Biologics and Devices. You will be part of Small Molecules. We are 9 dedicated and highly engaged employees working in the department.
In Global RA 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.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Farzana Hussain, Senior Manager, at + 45 5386 6594. . The deadline is June 6th 2021.
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred medical dermatology care partner. To fulfil this vision, we invest massively in development at all levels and enter new business areas e.g. oral treatments. As a member of RA CMC, you will get the opportunity to work with LEO Pharma’s products approved world-wide and bring innovative products to patients where there is still an unmet need for effective therapy.
As part of RA CMC Small Molecules, you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
As Regulatory Specialist you will be responsible for the project plan and project execution, provide and drive CMC regulatory input for the project strategy, interact with internal and external stakeholders (e.g. Health Authorities) and represent Regulatory Affairs in relevant cross organizational project teams. Here, you ensure regulatory deliverables within CMC according to agreed timelines and quality. As senior RA expert you will assume the role of the challenger who makes an impact, seeks solutions and drive discussions within RA CMC.
You will be part of the global regulatory teams being responsible for leading the CMC related discussions and regulatory activities for assigned projects. As a Regulatory Specialist, you will be overall responsible for the CMC deliverable ensuring submission and approval of clinical trial applications, for driving and coordinating preparation of or part of meeting packages to Health Authorities when related to CMC specific issues, prepare and conduct/attend Health Authority interactions and as part of the team for ensuring regulatory submissions and approvals. You will interact with subject matter experts within the CMC organization and collaborate and facilitate discussions with regulatory input obtained via your knowledge, peer discussions or engagement with the regulators. All in all, with the responsibility you will have a lot of influence and impact on the way we reach our goals.
You will report to the Senior Manager of RA CMC Small Molecules and take active part in department related activities, including improvement projects across RA.
Your qualifications
We expect you to have:
- A relevant advanced degree within Biotech (e.g. biopharmaceutical, biomedicine, biochemical engineer)
- Preferred experience (10+ years) within Regulatory Affairs within CMC
- Knowledge of regulatory requirements within EU and US and a broad knowledge of regulatory requirements in other markets and countries outside EU
- Solid experience of handling regulatory documentation for pharmaceutical development within the quality area and experience working with oral formulations will be an advantage
- Experience in interacting directly with regulatory authorities on an international scale
- Have proven strong negotiation skills and a sound business understanding
- Know how to set direction, lead and motivate your team to work for joint objectives. At the same time, you are the team player who assists your colleagues
- Clear focus on agreed objectives, even when working with tight deadlines.
As a person you are well organized and can approach and engage in challenging situations with solid problem-solving capabilities. You show a winning attitude, never let the goal out of sight and never lose your strategic focus. You are a skilled communicator and understand how to build efficient working relationships with both internal and external stakeholders. Finally, you are comfortable using fluent written and spoken English on a daily basis.
Your new team
RA CMC consist of three departments: Small Molecules, Biologics and Devices. You will be part of Small Molecules. We are 9 dedicated and highly engaged employees working in the department.
In Global RA 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.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Farzana Hussain, Senior Manager, at + 45 5386 6594. . The deadline is June 6th 2021.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 21.5.2021, 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.
- Apoteker
- Ballerup
- Søndag den 06. juni 2021
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