Global Regulatory Lead for Established Products
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Ballerup
Can you take regulatory lead on an ambitious growth strategy? Do you want to work a global strategic level, combined with overseeing tactical execution? Are you an experienced manager and/or do you want to take your project management skills to the next level? Then, we recommend you continue reading…
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. We have recently introduced our 2025 strategy, which aims to acceler-ate our efforts, among others, within our established portfolio to bring new opportunities for the portfolio to new markets globally, while at the same time ensuring we utilise all development and optimisation opportuni-ties in existing markets. You will play a significant role in making this happen. You will lead and execute on regu-latory strategies together with your team of dedicated RA Professionals.
The job is based at the LEO Pharma Headquarter in Ballerup, greater Copenhagen, Denmark.
Set the agenda for our regulatory strategies and be responsible for Life Cycle Management for your portfolio
As Global Regulatory Lead, your overall objective will be to lead, delegate and oversee execution of strategies, while continuously optimising processes and deliverables around your portfolio. As Global Lead, you will create and drive the global regulatory strategy and health authority interactions and ensure a sound regulatory foun-dation to optimize the clinical development and Life Cycle Management (LCM) opportunities of your portfolio. Some of your responsibilities include:
Lead a small team of Regulatory professionals. Develop regulatory strategies (including prioritizations opportunities) for global projects together with cross-functional team members in GRTs (global regulatory team). Drive and lead the regulatory agenda in the cross-organizational teams. Steer the planning cycle to ensure right resources at right time and place. Represent RA in development and implementation of new business areas and concepts. Build relations to RA colleagues and key stakeholders across the global organization. Contribute to the overall development of the RA function in LEO – strategy input etc.
Your key success criteria will be to build a competent and engaged team that from a global perspective support the local affiliates in their regulatory management of your portfolio. Also, your focus on optimisation and atomi-sation lead to rise in your team’s capacity and work processes.
Seasoned RA Project Manager / Manager with a strategic mindset and international experience
We expect you to hold a natural science degree and a minimum of 10 years’ experience within Regulatory Af-fairs. As such, you bring comprehensive and broad knowledge of regulatory affairs, guidelines and regulations, related theories and principles as well as hands-on experience within various regulatory submissions incl. expe-rience from EU-legislation.
Either you have experience from direct people management or have worked as project manager; in both sce-narios, you have learned how to lead, motivate, empower and develop your team members. Towards your stakeholders and relations, you have an open-minded approach and can work across cultural and professional borders. You present yourself as a driven person, striving to achieve ambitious objectives, while at the same time having a
pragmatic yes-can-do attitude. You make people believe in your ideas and convince them to support your agenda. Additionally, you have the communication skills to bridge different areas of expertise including the abil-ity to bring in new ideas when it makes sense.
Your new department
You will be part of Global Regulatory Strategy, Established Portfolio, and you will report to the Head of the de-partment and be part of a management team with 2 other Global Regulatory Leads. Our environment is charac-terised by a true passion for bringing products to patients, and we are highly motivated by being the ones that can lead the way through a complex regulatory landscape. We all work in an international setting with people from all over the world, and we like to share ideas with respect for personal, cultural and professional differ-ences. In total, we are more than 200 passionate professionals in Global Regulatory Affairs, and your team in-cludes 3 specialists working with the US and EU and assorted tasks.
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 im-prove 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 col-leagues 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.
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. We have recently introduced our 2025 strategy, which aims to acceler-ate our efforts, among others, within our established portfolio to bring new opportunities for the portfolio to new markets globally, while at the same time ensuring we utilise all development and optimisation opportuni-ties in existing markets. You will play a significant role in making this happen. You will lead and execute on regu-latory strategies together with your team of dedicated RA Professionals.
The job is based at the LEO Pharma Headquarter in Ballerup, greater Copenhagen, Denmark.
Set the agenda for our regulatory strategies and be responsible for Life Cycle Management for your portfolio
As Global Regulatory Lead, your overall objective will be to lead, delegate and oversee execution of strategies, while continuously optimising processes and deliverables around your portfolio. As Global Lead, you will create and drive the global regulatory strategy and health authority interactions and ensure a sound regulatory foun-dation to optimize the clinical development and Life Cycle Management (LCM) opportunities of your portfolio. Some of your responsibilities include:
Your key success criteria will be to build a competent and engaged team that from a global perspective support the local affiliates in their regulatory management of your portfolio. Also, your focus on optimisation and atomi-sation lead to rise in your team’s capacity and work processes.
Seasoned RA Project Manager / Manager with a strategic mindset and international experience
We expect you to hold a natural science degree and a minimum of 10 years’ experience within Regulatory Af-fairs. As such, you bring comprehensive and broad knowledge of regulatory affairs, guidelines and regulations, related theories and principles as well as hands-on experience within various regulatory submissions incl. expe-rience from EU-legislation.
Either you have experience from direct people management or have worked as project manager; in both sce-narios, you have learned how to lead, motivate, empower and develop your team members. Towards your stakeholders and relations, you have an open-minded approach and can work across cultural and professional borders. You present yourself as a driven person, striving to achieve ambitious objectives, while at the same time having a
pragmatic yes-can-do attitude. You make people believe in your ideas and convince them to support your agenda. Additionally, you have the communication skills to bridge different areas of expertise including the abil-ity to bring in new ideas when it makes sense.
Your new department
You will be part of Global Regulatory Strategy, Established Portfolio, and you will report to the Head of the de-partment and be part of a management team with 2 other Global Regulatory Leads. Our environment is charac-terised by a true passion for bringing products to patients, and we are highly motivated by being the ones that can lead the way through a complex regulatory landscape. We all work in an international setting with people from all over the world, and we like to share ideas with respect for personal, cultural and professional differ-ences. In total, we are more than 200 passionate professionals in Global Regulatory Affairs, and your team in-cludes 3 specialists working with the US and EU and assorted tasks.
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 im-prove 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 col-leagues 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.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 11.12.2019, 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.
- Produktspecialist
- Ballerup
- Søndag den 05. januar 2020
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