Senior Manager Regulatory Affairs CMC
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Ballerup
Can you deliver positive leadership and drive the global direction for regulatory affairs CMC in a time of rapid growth?
LEO Pharma has set the ambitious goal to become the world’s preferred dermatology care partner. To succeed, we invest massively in development at all levels, including R&D. As a result, our pipeline is growing rapidly in size and complexity, and therefore we need all your skills as leader, scientist and regulatory expert to build and set the bar for global regulatory CMC strategy.
You will join LEO Pharma at a very exciting period in the company’s history, and you can look forward to influence and impact on the shaping of your own job as well as the overall direction for the global regulatory CMC organisation in LEO Pharma.
Taking quality regulatory decisions, balancing risks and benefits
Regulatory Affairs CMC is divided in three teams with highly motivated employees, based both at LEO Pharma’s headquarters in Ballerup, Denmark as well as in Dublin, Ireland. You will lead one of these teams. Your overall objective is to manage all regulatory CMC aspects of LEO Pharma’s products throughout their lifecycle within your area of responsibility, and your primary tasks will be to:
Drive the regulatory CMC strategy in submissions for all products under your responsibility as well as being involved in interactions with regulatory authorities on CMC issues, working in partnership with R&D including Pharmaceutical Development Department, Global Product Supply, and QA Ensure global, efficient and compliant mindset, and business processes in Regulatory Affairs, driving an RA CMC platform for reducing time to patient access for new patient solutions and maintaining license to operate for current marketing authorizations supporting LEO aspirations and mission Manage and develop the direct reports, oversee development of indirect reports, ensure that the strategy and objectives are set, met and implemented, and driving performance to deliver on ambitious targets Interpret Regulatory Authority CMC policies, guidance, and emerging trends to apply them as appropriate in product development and post-approval activities
You can look forward to travel 20-40 days per year to meet colleagues and partners.
Experienced with strategic, global CMC Regulatory affairs and solid leadership skills
You have a natural science degree e.g. Master’s degree within natural science, e.g. pharmaceutics, biomedicine, engineering or similar. Preferably 5+ years leadership and management experience – resource management, capacity management, performance management, and change management.
This is backed by solid pharmaceutical development experience on a global scale. This has provided you with a strong knowledge base of Regulatory CMC on a global level for both development and maintenance phases of pharmaceuticals. You are recognised for being able to identify multiple regulatory opportunities, and for your ability to clearly communicate regulatory constraints, risks, and mitigation opportunities.
You have experience as people manager, and you are known for your open-minded and positive leadership style. Even though you thrive on setting the direction and taking the lead, nothing motivates you like making your people shine and be their best. Additionally, you have the toolbox to build, motivate and inspire high performance teams with a common drive for success. In this you take benefit from your excellent communication skills that enable you to bring your messages across in an easy understandable way, written as spoken. As part of a rapidly growing organisation you must also thrive in an environment of change and be able to navigate safely without having manuals and updated SOP’s for each and every process.
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 Local RA and partners.
LEO Pharma has set the ambitious goal to become the world’s preferred dermatology care partner. To succeed, we invest massively in development at all levels, including R&D. As a result, our pipeline is growing rapidly in size and complexity, and therefore we need all your skills as leader, scientist and regulatory expert to build and set the bar for global regulatory CMC strategy.
You will join LEO Pharma at a very exciting period in the company’s history, and you can look forward to influence and impact on the shaping of your own job as well as the overall direction for the global regulatory CMC organisation in LEO Pharma.
Taking quality regulatory decisions, balancing risks and benefits
Regulatory Affairs CMC is divided in three teams with highly motivated employees, based both at LEO Pharma’s headquarters in Ballerup, Denmark as well as in Dublin, Ireland. You will lead one of these teams. Your overall objective is to manage all regulatory CMC aspects of LEO Pharma’s products throughout their lifecycle within your area of responsibility, and your primary tasks will be to:
You can look forward to travel 20-40 days per year to meet colleagues and partners.
Experienced with strategic, global CMC Regulatory affairs and solid leadership skills
You have a natural science degree e.g. Master’s degree within natural science, e.g. pharmaceutics, biomedicine, engineering or similar. Preferably 5+ years leadership and management experience – resource management, capacity management, performance management, and change management.
This is backed by solid pharmaceutical development experience on a global scale. This has provided you with a strong knowledge base of Regulatory CMC on a global level for both development and maintenance phases of pharmaceuticals. You are recognised for being able to identify multiple regulatory opportunities, and for your ability to clearly communicate regulatory constraints, risks, and mitigation opportunities.
You have experience as people manager, and you are known for your open-minded and positive leadership style. Even though you thrive on setting the direction and taking the lead, nothing motivates you like making your people shine and be their best. Additionally, you have the toolbox to build, motivate and inspire high performance teams with a common drive for success. In this you take benefit from your excellent communication skills that enable you to bring your messages across in an easy understandable way, written as spoken. As part of a rapidly growing organisation you must also thrive in an environment of change and be able to navigate safely without having manuals and updated SOP’s for each and every process.
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 Local RA and partners.
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 28.1.2020, 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.
- Apoteker
- Ballerup
- Søndag den 16. februar 2020
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