Senior Global Regulatory Lead – Senior Manager (DK)
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Ballerup
Do you like to make things happen? Do you have solid regulatory affairs (RA) experience, and are you able to take the regulatory lead on a very ambitious growth strategy? Then this job could be your perfect match.
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 of time. 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 you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job as Senior Global Regulatory Lead you will create and drive the global regulatory strategy for a product(s) / project(s) and ensure there is a sound regulatory foundation for the successful optimization of the product(s) /project(s) in accordance with business priorities working closely with RA subfunctions (including regional RA leads) and global cross-functional stakeholders (e.g., medical affairs, marketing, market access) where required to ensure alignment on global project strategy.
Ideally, you will be working from our HQ's in Ballerup, but we are also open to candidates working remotely from an EU country, in which case regular travel to Denmark should be anticipated.
The ideal candidate will maintain expert knowledge of region and ICH guidance and familiarity with FDA/EMA/key international market regulations and competitive intelligence/landscape. The candidate will provide clear and valid regulatory guidance, interpretation by applying ‘out of the box thinking’ mind set, direction to GRT , GPT and other global functional subteams. She/he will act pro-actively and sustain a good stakeholder collaboration within GRA and across the LEO Pharma organization via continuous stakeholder management. Your qualifications
We are looking for a team player and pioneer with a strategic global mindset, who can see opportunities and possible solutions when facing tough challenges. You know how to develop team members through coaching and feedback. You have strong and effective stakeholder management skills, and you have the persistence to keep on going. 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 team of skilled and dedicated regulatory strategists. We are responsible for creating and driving regulatory strategies for successful optimization of products /projects within the Innovative Portfolio in accordance with business priorities. We are based in Ballerup, Greater Copenhagen and in Madison, NJ USA.
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 Antonella Lozito-Heerschap, Head of Global Regulatory Strategy, Global Regulatory Strategy - Innovativ - [email protected]
. The deadline is November 15th 2020.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.
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 of time. 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 you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job as Senior Global Regulatory Lead you will create and drive the global regulatory strategy for a product(s) / project(s) and ensure there is a sound regulatory foundation for the successful optimization of the product(s) /project(s) in accordance with business priorities working closely with RA subfunctions (including regional RA leads) and global cross-functional stakeholders (e.g., medical affairs, marketing, market access) where required to ensure alignment on global project strategy.
- Strategic lead of the Global Regulatory Team (GRT) and overall accountable for creating and driving global regulatory strategies for assigned project(s)/product(s) within the Innovative Portfolio.
- Define regulatory strategic direction, review and provide critical regulatory input into documents that will be included in regulatory applications and interactions, as applicable
- Accountable for securing coordination, preparation and timely submission and approval of various original and variation filings (e.g., INDs/CTAs, MAAs, NDAs/BLAs, MAV/sNDA)
- Represents GRA to Global Project Teams (GPT) within the Innovative Portfolio
- Act as people manager for a team of dedicated EU, US leads and Regulatory Professionals, as allocated
- Allocate budgets within predefined portfolio.
Ideally, you will be working from our HQ's in Ballerup, but we are also open to candidates working remotely from an EU country, in which case regular travel to Denmark should be anticipated.
The ideal candidate will maintain expert knowledge of region and ICH guidance and familiarity with FDA/EMA/key international market regulations and competitive intelligence/landscape. The candidate will provide clear and valid regulatory guidance, interpretation by applying ‘out of the box thinking’ mind set, direction to GRT , GPT and other global functional subteams. She/he will act pro-actively and sustain a good stakeholder collaboration within GRA and across the LEO Pharma organization via continuous stakeholder management. Your qualifications
We are looking for a team player and pioneer with a strategic global mindset, who can see opportunities and possible solutions when facing tough challenges. You know how to develop team members through coaching and feedback. You have strong and effective stakeholder management skills, and you have the persistence to keep on going. 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's or bachelor's degree within natural science or equivalent. Advanced degree preferred
- 10 years pharmaceutical industry and relevant increasing global strategic regulatory experience, including leading achievement of major regulatory milestones (with major business impact), including drug development milestones (e.g., EOP2) and/or life cycle management milestones (e.g., line extensions)
- Solid experience of the regulatory framework on a global level from both development- and life cycle management phases of drug development
- Experience with due diligence preferred
- Managerial and leadership experience of 5 years preferred
- Broad business understanding and knowing the business and the impact of the project.
Your new team
You will join a team of skilled and dedicated regulatory strategists. We are responsible for creating and driving regulatory strategies for successful optimization of products /projects within the Innovative Portfolio in accordance with business priorities. We are based in Ballerup, Greater Copenhagen and in Madison, NJ USA.
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 Antonella Lozito-Heerschap, Head of Global Regulatory Strategy, Global Regulatory Strategy - Innovativ - [email protected]
. The deadline is November 15th 2020.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.
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 5.10.2020, 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.
- Produktspecialist
- Ballerup
- Søndag den 15. november 2020
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