Associate Director for Global Roll Out

2 days ago

Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

Do you want to work globally in an innovative company making products available for patients worldwide?

We offer you an exciting and challenging position in an entrepreneurial and international company, with a short line of command. As our new Associate Director, you will be responsible for activities that are central to Ascendis Pharma’s global strategy, and you will work cross functionally to identify the best regulatory opportunities for bringing a new product to the patients.

Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark, that offers you room to grow and the freedom to take responsibility and make a difference for patients every day. As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline. The position is an extension of our existing team due to growing portfolio.

We are looking for an experienced Regulatory Affairs CMC (RA CMC) Associate Director, who will be responsible for RA CMC strategy support to second line regulatory approvals, as well as development and life cycle activities for a product that recently obtained first market approval in late-stage development. You will also be involved in building up our internal standards and processes in support of global regulatory activities.

You will be responsible for planning and driving regulatory activities and deliverables according to Ascendis business strategy and to agreed timelines. You will be the overall accountable for specific deliverables such as:

  • Understanding the regulatory requirements and establish the regulatory strategy for submission of second line marketing applications, global clinical trial applications, post approval changes & 2nd generation development.
  • Planning, submission, and approval of applications in collaboration with our global partners.
  • Driving and coordinating preparation of meeting packages and response strategies to Health Authorities, and for liaising and negotiating with global regulatory authorities.
  • Managing new and pending IMPDs and INDs, and compassionate use programs.
  • Review and approval of regulatory documentation and response packages.
  • Build partnerships with key stakeholders from other functions and external partners to ensure that strategic business goals are met through sharing knowledge, and expertise.
  • Contribute to internal regulatory policies and procedures, to develop best practices and work processes.

The successful applicant preferably:

  • Holds a Master’s degree within Natural Science or a related field.
  • Has a proven record of broad regulatory experience and documented professional experience from a Regulatory Affairs CMC position in the pharma industry.
  • Is highly committed to deliver outstanding results within the established timelines.
  • Has the ability to build trust and respect within the organization.
  • Possesses strong collaboration and stakeholder management skills.
  • Thinks creatively and develops creative solutions and has a hands-on attitude.
  • Possesses excellent collaboration and communication skills.
  • You are proficient in English at a professional level, both written and spoken.

Another essential factor to succeed in this role is your ability to contribute to the teamwork culture, provide support and share knowledge with your colleagues.

As our new Associate Director, you will be working in a well-established and team-oriented department, currently consisting of eleven very experienced and dedicated colleagues supporting each other by actively sharing learnings and experience. You will be working closely together with Danish and US colleagues across Regulatory Affairs, CMC Development, Product Supply, Quality Assurance, and with our global partners. Daily, you will have many internal and external stakeholder interactions.

We will actively be supporting your professional development by providing appropriate training, hands-on experience, and the opportunity to learn from experienced colleagues.

Your place of work will be in the Ascendis Pharma facility in a modern office facility in Tuborg Havn in Hellerup, with a view of the harbour, the canals, and the sea. We offer flexibility in working hours and the possibility to work partly from home.

You apply for the position by uploading your CV. You do not need to attach a cover letter, but you will be asked to respond to the following questions, when you are uploading your documents:

  • Why do you apply for this position?
  • How will your personal and regulatory skills provide value to Ascendis?
  • What do you expect from your colleagues?

All applications must be in English and are treated confidentially. We will review applications when received, and candidates may be called for interview before the deadline.

Please notice that Ascendis Pharma does not offer mobility service for this position.

For more details about this position please contact Bente Brunbakke, Senior Director, Regulatory Affairs CMC by email to

Hellerup

#J-18808-Ljbffr

  • Volvo Maskin AS søker Managing Director

    2 days ago

    Gentofte Kommune, Denmark Director File Full time

    Managing Director to Volvo Construction Equipment in Norway Who we are and what we believe in: Our focus on Inclusion, Diversity, and Equity allows each of us the opportunity to bring our full authentic self to work and thrive by providing a safe and supportive environment, free of harassment and discrimination. We are committed to removing the barriers to...

  • Associate Global Product Manager

    2 days ago

    Glostrup Kommune, Denmark Agilent Technologies Full time

    Job Description Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the...

  • Global Value Strategy and Payer Engagement Associate Director

    1 week ago

    Gladsaxe Kommune, Denmark Novo Nordisk AS Full time

    Select how often (in days) to receive an alert: Create Alert Global Value Strategy and Payer Engagement Associate Director Category: Market Access Location: Søborg, Capital Region of Denmark, DK Do you want to shape market access strategies to change the future paradigm of Obesity products? Do you have experience within market access in pharmaceutical and...

  • Global Medical Director External Programs

    2 days ago

    Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    Global Medical Director External Programs ASCENDIS PHARMA A/S Are you passionate about changing the lives of people living with rare diseases? Do you have experience leading the development and execution of Global Medical Affairs external programs? If so, now is your chance to join Ascendis Pharma as our new Global Medical Director External Programs. ...

  • Senior Regulatory Affairs Director for Global Strategy

    1 day ago

    Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    Embark on an exciting career opportunity with Ascendis Pharma A/S, a fast-growing dynamic biopharmaceutical company. As our new Senior Regulatory Affairs Director for Global Strategy, you will play a pivotal role in driving the company's global strategy forward.Job Description:As a member of our Regulatory Affairs team, you will be responsible for developing...

  • Associate Director, Regional lead Capex DK

    2 days ago

    Aarhus kommune, Denmark Arla Foods Deutschland GmbH Full time

    Associate Director, Regional lead Capex DK - Viby Location: Viby J, DK Do you have a track record of delivering large engineering/CAPEX projects? Are you looking for a position where your work has a real purpose and clear impact on the future growth of Arla Foods? Then this exciting opportunity within our Engineering & Technology team could be just the right...

  • Global Client Group, Nordic Sales Support Associate, Based in Copenhagen

    7 days ago

    Gentofte Kommune, Denmark TIAA Full time

    Overview of the Role Given the growth of the Nordic business, an opportunity has arisen for a Sales Associate to support the Nordic distribution team within Nuveen’s Global Client Group. The role is based out of Copenhagen with primary focus on Denmark/Norway but will support the wider Nordic Distribution team which includes colleagues in Stockholm. The...

  • Healthcare Compliance Senior Specialist,

    2 days ago

    Gentofte Kommune, Denmark Best Talent Full time

    The Company Ascendis Pharma A/S, a U.S. publicly held biopharmaceutical company founded in Copenhagen, Denmark in 2007, is committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by...

  • Audit Manager

    2 days ago

    Gentofte Kommune, Denmark Saxo Bank AS Full time

    About The Job We are growing our team in Saxo Group Internal Audit (GIA) and therefore, we are looking for more great colleagues to join us! GIA is responsible for carrying out risk-based operational audits across the organisation and its subsidiaries. Reporting directly to the Board of Directors, GIA helps to ensure that the organisation effectively...

  • Global Project Director

    4 days ago

    Gladsaxe Kommune, Denmark Novo Nordisk AS Full time

    Do you find it interesting to be part of an organization that is dedicated to making a positive impact on people's lives? Are you motivated by the opportunity to transform how we work with (gen)AI in RWE and evidence generation? Are you passionate about evidence and RWE as means to optimize Market Access for an innovative pipeline? If yes, then Novo Nordisk...

  • Leaders to Associate Manager Pipeline

    2 days ago

    Gentofte Kommune, Denmark Novo Nordisk AS Full time

    Jobbeskrivelse Placering Gentofte, Denmark Jobkategori Manufacturing Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? Maybe you have a strong leadership background, or you might be at the start of your leadership career – we have opportunities at all levels making it possible to challenge you and put your skills into...

  • Global HEOR Director, Rare Disease

    2 days ago

    Gladsaxe Kommune, Denmark Novo Nordisk AS - Nn1 Full time

    Are you ready to make a meaningful impact in the realm of rare disease treatment access? As the Global Director for Health Economics & Outcomes Research, you will be at the forefront of pioneering initiatives that shape the way rare disease treatments are perceived, valued, and accessed worldwide, making a tangible difference in the lives of the patients and...

  • Global Medical Director

    4 days ago

    Gladsaxe Kommune, Denmark Novo Nordisk AS Full time

    Select how often (in days) to receive an alert: Create Alert Global Medical Director - Heart Failure - Parental Cover Category: Medical Affairs Location: Søborg, Capital Region of Denmark, DK Are you looking for an opportunity where you can utilize your leadership skills and medical knowledge to generate, interpret and communicate scientific data? Does...

  • Renewable Energy Specialist

    1 week ago

    Gentofte, Gentofte Kommune, Denmark EarthStream Global Full time

    Job DescriptionAt EarthStream Global, we are seeking a skilled Wind Energy Analyst to join our team. In this role, you will play a crucial part in assessing wind resources for utility-scale wind farms, performing data analyses, and preparing layouts.About the RoleYou will be responsible for evaluating wind resources, including assessing potential energy...

  • Client Service Associate

    2 days ago

    Gentofte Kommune, Denmark Saxo Bank AS Full time

    About the Job: We get curious people invested in the world. We believe access to global capital markets is not only for the privileged few. Our vision is to enable people to fulfill their financial aspirations to make an impact. That is why we use the power of technology to deliver clients what they need, when they need it in a user-friendly and...

  • Three Group Leaders

    2 days ago

    Gentofte Kommune, Denmark Københavns Universitet (KU) Full time

    Three Group Leaders (Associate Professor or Professor) in Cardiometabolic Health and Disease Novo Nordisk Foundation Center for Basic Metabolic Research Faculty of Health and Medical Sciences University of Copenhagen The University of Copenhagen seeks to appoint up to three Group Leaders at Associate Professor or Professor level in Cardiometabolic Health...

  • Global Trial Manager

    4 days ago

    Gladsaxe Kommune, Denmark Novo Nordisk AS Full time

    Are you passionate about clinical development? Is ensuring that clinical trials produce high-quality data and scientific documentation your top priority? If so, we want you to join our team in Clinical Operations, Rare Disease as a Global Trial Manager. Read more and apply today for a life-changing career. The position In this role you will get the...

  • Group HR Director

    2 days ago

    Aarhus kommune, Denmark Hansen Toft Full time

    Group HR Director Etablere og eksekvere en global HR-agenda som led i en større transformation. Via en nyoprettet stilling som Group HR Director ønsker Micro Matic A/S at skabe en globalt koordineret HR-agenda med det formål at skabe en gradvis overgang mod en fælles kultur, ramme og retning for organisationen. Bredt ansvarsområde på strategisk såvel...

  • Director - Inbound Logistics

    2 days ago

    Aarhus kommune, Denmark Arla Foods Deutschland GmbH Full time

    Are you ready to take charge of a dynamic team, collecting 5 billion kg of milk from our Danish farmers, moving 1.4 billion kg of co-products between dairies and out to our customers? And are you passionate about optimizing operations, implementing innovative solutions, securing great collaboration, and ensuring health and safety for all colleagues in the...

  • Director - Inbound Logistics

    2 days ago

    Aarhus kommune, Denmark Arla Foods amba Full time

    Location: Viby J, DK Are you ready to take charge of a dynamic team, collecting 5 bill. Kg of milk from our Danish farmers, moving 1,4 bill. kg co. products between dairies and out to our customers? And are you passionate about optimizing operations, implementing innovative solutions, securing great collaboration, and ensuring health and safety for all...