Global Regulatory Affairs Director

23 hours ago


Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time
Overview

At Ascendis Pharma A/S, we are seeking an experienced and skilled Global Regulatory Affairs Director to join our dynamic team. With a focus on innovation and patient care, we strive to make a meaningful difference in the lives of patients worldwide.

Job Summary

We are looking for a seasoned professional with a proven track record in regulatory affairs to lead our global regulatory strategy and initiatives. As a key member of our team, you will be responsible for driving regulatory activities and deliverables that align with our business strategy and objectives.

Key Responsibilities
  • Develop and implement global regulatory strategies to support second-line marketing applications, clinical trials, and post-approval changes.
  • Collaborate with global partners to plan, submit, and obtain approvals for regulatory applications.
  • Coordinate preparation of meeting packages and response strategies for Health Authorities and liaise with global regulatory authorities.
  • Manage new and pending IMPDs and INDs, as well as compassionate use programs.
  • Review and approve 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.
Requirements
  • A Master's degree within Natural Science or a related field.
  • A proven record of broad regulatory experience and documented professional experience from a Regulatory Affairs CMC position in the pharma industry.
  • The ability to build trust and respect within the organization.
  • Strong collaboration and stakeholder management skills.
  • Excellent communication and problem-solving skills.
  • You are proficient in English at a professional level, both written and spoken.
What We Offer

We offer a competitive salary of approximately $120,000 per year, based on the location and industry standards. Additionally, you will have the opportunity to work in a modern office facility in Tuborg Havn, Hellerup, with a view of the harbour, canals, and sea. We also offer flexibility in working hours and the possibility to work partly from home.

About Us

Ascendis Pharma A/S is a fast-growing, dynamic biopharmaceutical company with headquarters in Denmark. We are committed to advancing our product pipeline and making a meaningful difference in the lives of patients worldwide.



  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    At Ascendis Pharma A/S, we offer an exciting opportunity to join our team as a Regulatory Affairs CMC Director for Global Product Development.We are a fast-growing biopharmaceutical company based in Denmark, with a global presence and a portfolio of innovative products. Our company is committed to making a difference in patients' lives by developing and...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    Company OverviewAscendis Pharma A/S is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark.Salary and BenefitsThe estimated salary for this position is between 120,000 - 180,000 DKK per year, depending on experience. In addition to the base salary, we offer a range of benefits including flexible working hours, the possibility to...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    Key Responsibilities:The successful candidate will be responsible for planning and driving regulatory activities and deliverables according to Ascendis Pharma's business strategy and to agreed timelines.Key Deliverables:Understanding the regulatory requirements and establish the regulatory strategy for submission of second line marketing applications, global...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    We are seeking a highly skilled Global Medical Director External Programs to join our team at Ascendis Pharma A/S.This role plays a crucial part in leading the development and execution of Global Medical Affairs external programs across the endocrine portfolio, encompassing tasks such as Investigator Initiated Studies management, Early Access Program...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    Lead Global Medical Affairs Strategy at ASCENDIS PHARMA A/SWe are seeking a passionate leader to join our team as Global Medical Director External Programs. This key role involves overseeing the development and execution of Global Medical Affairs external programs across the endocrine portfolio at above-country level. You will lead various projects and...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    About UsAscendis Pharma A/S is a fast-growing biopharmaceutical company with locations in Denmark, Germany, the United States, UK, Italy, Spain, and France. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives.Job OverviewWe are seeking an...


  • Gentofte, Gentofte Kommune, Denmark Best Talent Full time

    About the RoleBest Talent is seeking a Senior PV Quality Manager to join our client's team in Copenhagen, Denmark. As a key member of the Global Quality team, you will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in Pharmacovigilance and Regulatory Affairs.Key ResponsibilitiesPlan, perform, and...


  • Gentofte, Gentofte Kommune, Denmark Director File Full time

    Global Sustainability Leader for Volvo Construction Equipment in NorwayWe are looking for a forward-thinking leader to drive our sustainability journey in Norway. As Global Sustainability Leader for Volvo Construction Equipment in Norway, you will be part of an unprecedented transformation journey.Your key responsibilities will include driving our business...


  • Gentofte, Gentofte Kommune, Denmark Unique Human Capital AS Full time

    Are you passionate about ensuring the highest quality of patient handling solutions?About the Role:We are seeking a highly skilled Quality Assurance Specialist to join our Patient Handling Division. As a key member of our team, you will be responsible for all quality assurance activities within the division, including regulatory approvals, quality management...


  • Gentofte, Gentofte Kommune, Denmark Director File Full time

    Leadership Opportunity for Volvo Construction Equipment in NorwayWe are seeking an experienced leader to drive the growth and sustainability of our operations in Norway.The successful candidate will have a strong track record in leading strategy formulations, operational excellence, and continuous improvement. They will be responsible for ensuring the...


  • Gentofte, Gentofte Kommune, Denmark Saxo Bank AS Full time

    About Saxo Bank A/SCopenhagen, Denmark based Saxo Bank A/S is seeking a skilled professional to join our Global Tax Reporting team as a Senior Tax Reporting Specialist.As a key member of the team, you will be responsible for conducting detailed analysis and requirements to comply with Saxo's compliance and reporting obligations within several jurisdictions...


  • Gentofte, Gentofte Kommune, Denmark Ascendis Pharma AS Full time

    Lead Competitive Intelligence in EndocrinologyThe Market Intelligence department's primary objective is to keep the business optimally informed on developments in the competitive landscape, supporting sustainable growth and ensuring Ascendis Pharma remains agile and competitive in a rapidly evolving industry.In this role, you will play a critical part in...


  • Gentofte, Gentofte Kommune, Denmark Ascendis Pharma AS Full time

    Job DescriptionAt Ascendis Pharma A/S, we are seeking a skilled Pharmaceutical Product Expert to join our team. This exciting opportunity will enable you to utilize your expertise in drug product manufacturing and regulatory requirements.About the RoleWe are looking for an experienced professional with a strong background in aseptic processing and regulatory...


  • Gentofte, Gentofte Kommune, Denmark Bikubenfonden Full time

    Job Summary">We are seeking an experienced Global IT Operations Manager to join our Corporate IT Team in Tuborg Havn. As a key member of our team, you will be responsible for the global IT service and operational setup in our offices outside Denmark.">About the Role">In this role, you will manage all aspects of the global IT service and activities related to...


  • Gentofte, Gentofte Kommune, Denmark Novonordiskfonden Full time

    Job DescriptionWe are seeking an experienced Global IT Operations Manager to join our team at Novo Nordisk Foundation. The successful candidate will be responsible for driving the continued development of our global IT service and ensuring its high quality and continuous improvement.Key Responsibilities:Manage the global IT service and operations setup...


  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    Job DescriptionThis role is focused on ensuring the highest quality and safety of our products through effective GMP inspections. The ideal candidate will have experience in the pharmaceutical industry, particularly in production or QA, and be able to demonstrate strong stakeholder management and networking skills.About UsNovo Nordisk A/S is a leading global...


  • Gentofte, Gentofte Kommune, Denmark Saxo Bank AS Full time

    About SaxoCopenhagen is the home of Saxo Bank A/S, a dynamic organization with a steep learning curve.We are looking for a motivated individual to join our Global Tax Reporting team, where you will help us manage the global tax landscape on behalf of our clients and partners.As a Tax Reporting Associate, you will be part of a team of specialists responsible...


  • Gentofte, Gentofte Kommune, Denmark Director File Full time

    Senior Executive to Drive Sustainability and GrowthWe are a global leader in the industry, committed to building a better future through efficient, safe, and sustainable solutions. Our purpose is to empower people to make a difference, and we're looking for a strategic leader to join our team.The ideal candidate will have experience in leading strategy...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    Ascendis Pharma A/S offers an exciting opportunity to join our GCP Quality team as a Senior Quality Assurance Manager. We are a leading biopharmaceutical company with locations in Denmark, Germany, and the United States.About UsWe apply our TransCon technology to build a fully integrated biopharmaceutical company focused on making a meaningful difference in...


  • Gentofte, Gentofte Kommune, Denmark Bikubenfonden Full time

    Job DescriptionWe are seeking a highly skilled Global IT Operations Manager to join our team in Tuborg Havn. As a key member of the Corporate IT Team, you will be responsible for driving the continued development and standardization of our global IT service.The ideal candidate will have extensive experience managing international services and vendors, as...