EU+ Regulatory Lead, Principal Professional, Innovative Portfolio
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Can you bring profound knowledge across RA, and are you looking for a unique opportunity to further you career?
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. You will enter LEO Pharma at the most exciting period. Right now, we are transforming the business to meet the requirements of tomorrow, maximizing opportunities by defining differentiated global regulatory strategies with optimized roll out plans.
In Global Regulatory Affairs (GRA) you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
As Principal Regional Regulatory Lead your overall objectives will be to create and drive the regional regulatory strategy for a key strategic project/product and ensure a sound regulatory foundation for the successful optimization of the product in accordance with business priorities. You will be working closely with the global team, local RA, and regional cross-functional stakeholders (e.g. medical affairs, marketing, market access) where required to ensure alignment on global strategy via the Global Regulatory Team (GRT).
Your primary tasks will be:
Your qualifications:
We are looking for a team player and pioneer with a global mindset, who can see opportunities and possible solutions when facing tough challenges. You are proactive thinking and have a ‘yes-can-do’ attitude. You have strong and effective stakeholder management skills whereby you anticipate and balance the needs of multiple stakeholders. You are proactive and curious with the ability to find the most feasible regulatory pathway. You think locally and act globally – and you think globally and act locally. Your professional skillset comprises:
Your new team
You will join a small but dedicated team of regulatory strategists. We are responsible for creating and driving regulatory strategies of a key project that has recently obtained approval in EU product for successful optimization in accordance with business priorities. We are based at the LEO headquarters in Ballerup, Greater Copenhagen.
Do you want to know more?
For further information, please contact Christian Oerum Olesen, Senior Manager, Innovative 1: Tralokinumab, Portal. at +45 3148 2519.
Applications will be evaluated, and candidates interviewed, on an ongoing basis so please do not hesitate in making your application. Deadline no later than November 14th 2021.
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world. Global Research and Development (GRD) is on the forefront of this journey. GRD is a global team, spread across the world consisting of approximately 1000 permanent employees. We drive the execution of all of LEO Pharma’s drug discovery, design and development together with stakeholders and partners across LEO Pharma as well as external partners around the world.
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. You will enter LEO Pharma at the most exciting period. Right now, we are transforming the business to meet the requirements of tomorrow, maximizing opportunities by defining differentiated global regulatory strategies with optimized roll out plans.
In Global Regulatory Affairs (GRA) you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
As Principal Regional Regulatory Lead your overall objectives will be to create and drive the regional regulatory strategy for a key strategic project/product and ensure a sound regulatory foundation for the successful optimization of the product in accordance with business priorities. You will be working closely with the global team, local RA, and regional cross-functional stakeholders (e.g. medical affairs, marketing, market access) where required to ensure alignment on global strategy via the Global Regulatory Team (GRT).
Your primary tasks will be:
- Primary regulatory representative and responsible for their region in relation to overall project strategy (working with local RA where required)
- Primary contact to the EMA for life-cycle management activities including pediatric development
- Responsible for the regional regulatory strategy and ensuring alignment with commercial plans and priorities to optimize portfolio.
- Responsible for regulatory interactions, and submissions, with strategic accountability for the regional filings while leveraging their GRT subject matter experts and endorsed by GRT.
- Manage coordination, preparation and timely submission and approval of various original and variation filings for their region, working in a global collaborative manner. Ensure timely follow up and execution according to agreed timelines.
- Provide clear and valid regulatory guidance, interpretation by applying 'out of the box thinking' mind set, direction to GRT and region of responsibility.
- Maintain expert knowledge of region and ICH guidance and familiarity with competitive intelligence/landscape.
Your qualifications:
We are looking for a team player and pioneer with a global mindset, who can see opportunities and possible solutions when facing tough challenges. You are proactive thinking and have a ‘yes-can-do’ attitude. You have strong and effective stakeholder management skills whereby you anticipate and balance the needs of multiple stakeholders. You are proactive and curious with the ability to find the most feasible regulatory pathway. You think locally and act globally – and you think globally and act locally. Your professional skillset comprises:
- Master or degree within natural science or equivalent
- 10+ years pharmaceutical industry and relevant local and/or global strategic regulatory experience, including leading achievement of major regulatory milestones (e.g., line extensions, major variations, scientific advice)
- Advanced understanding of both drug development and life-cycle management including pediatric development, health authority interactions, and label updates
- Expert knowledge of EMA guidelines, requirements, and precedence to inform strategic regional considerations
- Regional business acumen
Your new team
You will join a small but dedicated team of regulatory strategists. We are responsible for creating and driving regulatory strategies of a key project that has recently obtained approval in EU product for successful optimization in accordance with business priorities. We are based at the LEO headquarters in Ballerup, Greater Copenhagen.
Do you want to know more?
For further information, please contact Christian Oerum Olesen, Senior Manager, Innovative 1: Tralokinumab, Portal. at +45 3148 2519.
Applications will be evaluated, and candidates interviewed, on an ongoing basis so please do not hesitate in making your application. Deadline no later than November 14th 2021.
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world. Global Research and Development (GRD) is on the forefront of this journey. GRD is a global team, spread across the world consisting of approximately 1000 permanent employees. We drive the execution of all of LEO Pharma’s drug discovery, design and development together with stakeholders and partners across LEO Pharma as well as external partners around the world.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Storkøbenhavn
Jobbet er oprettet på vores service den 10.9.2021, 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.
- Øvrige
- Storkøbenhavn
- Søndag den 14. november 2021
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