Global Regulatory CMC Director

2 weeks ago


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 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.

Requirements:

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.


  • 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

    Global Medical Director External ProgramsAre 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.Ascendis Pharma is a...


  • 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

    Global Medical Director External ProgramsWe are seeking a seasoned medical professional to lead our Global Medical Affairs external programs. As a key member of our team, you will play a crucial role in overseeing the development and execution of external programs across our endocrine portfolio at a global level.Main Responsibilities:Program Planning 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 Novo Nordisk AS Full time

    About the RoleWe are seeking a Senior Drug Product Manager to join our team at Novo Nordisk A/S. As a key member of our Rare Disease department, you will play a vital role in ensuring the smooth operation of marketed products and bringing new treatments to market.Key ResponsibilitiesLead drug product life cycle management activities, ensuring quality and...


  • 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

    About the RoleWe are seeking a skilled Senior Drug Product Manager to join our team at Novo Nordisk A/S. This is an exciting opportunity for a collaborative and proactive individual to drive change in the rare disease areas of hemophilia and growth hormone deficiencies.Job DescriptionAs a Senior Drug Product Manager, you will be responsible for ensuring the...


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

    About Saxo Bank A/SCopenhagen, DenmarkWe are seeking a highly skilled Senior Compliance Officer to join our ambitious compliance team at Saxo Bank A/S. As a key member of our Regulatory Tax Reporting domain, you will play a vital role in supporting our business in meeting regulatory requirements in a dynamic and international environment.In this challenging...


  • 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 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 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...


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

    About Saxo Bank A/SCopenhagen, Denmark is home to our global headquarters and the epicenter of our Financial Crime Prevention efforts.As a Master Trainer at Saxo, you will play a pivotal role in developing and delivering high-quality training programs that equip colleagues with the skills and knowledge needed to combat financial crime globally.We are seeking...


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

    We are Saxo Bank A/S, a leading global online trading and investment specialist.Our vision is to empower individuals to fulfill their financial aspirations and make an impact.To achieve this, we need talented professionals like you to join our Client Service team located at our Headquarters in Copenhagen.About the RoleIn this role as a Client Service...


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

    At Ascendis Pharma A/S, we're driven by our passion for transforming patients' lives through innovative therapies. Our cutting-edge TransCon technology has enabled us to establish a fully integrated biopharmaceutical enterprise with a strong presence in Denmark, Germany, and the United States.We're currently seeking a skilled Development Quality Assurance...


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

    En unik mulighed for at drive den kommercielle retning og styrke salgsindsatsen i koncern med internationalt udsyn.Som Senior Commercial Director hos Unique Human Capital A/S bliver du del af en veldrevet, børsnoteret og signifikant nicheaktør med lange og dybe kompetencer inden for feltet tekniske fiberprodukter. Markederne er konsoliderede, og kunderne...


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

    About the RoleWe're seeking a skilled Quality Assurance Specialist to join our Development QA team in Copenhagen. As a vital contributor, you'll play a key role in ensuring the quality oversight of outsourced development activities at our Contract Laboratories and Manufacturing Organizations.Main ResponsibilitiesDrive quality oversight for development...


  • 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 Novo Nordisk AS Full time

    Estimated salary: $130,000 - $170,000 per yearAbout the RoleWe are seeking a highly skilled and experienced Executive Director to lead our IT/OT Project Management Office team. As a key member of our Digital, Data & IT Product Supply Finish Product Management leadership team, you will be responsible for overseeing the successful delivery of cutting-edge...