Global Regulatory Affairs Director for Product Roll Out and Strategy
2 days ago
We are seeking an experienced Regulatory Affairs CMC Associate Director to join our dynamic team at Ascendis Pharma A/S in Hellerup, Denmark. This is a unique opportunity to drive global regulatory activities and contribute to the company's growth.
About UsAscendis Pharma A/S is a fast-growing biopharmaceutical company with headquarters in Denmark. Our innovative products aim to make a difference for patients worldwide.
Job DescriptionThis position involves planning and driving regulatory activities according to the company's business strategy. You will be responsible for RA CMC strategy support, including second-line regulatory approvals, development, and life cycle activities for a product that has recently obtained first market approval in late-stage development.
- Develop and implement RA CMC strategies for submission of second-line marketing applications, global clinical trial applications, post-approval changes & 2nd generation development.
- Plan, submit, and obtain approval of applications in collaboration with our global partners.
- Drive and coordinate preparation of meeting packages and response strategies to Health Authorities, and liaise and negotiate with global regulatory authorities.
- Manage new and pending IMPDs and INDs, and compassionate use programs.
- Review and approve regulatory documentation and response packages.
- Build partnerships with key stakeholders from other functions and external partners to ensure strategic business goals are met through sharing knowledge and expertise.
- Contribute to internal regulatory policies and procedures, developing best practices and work processes.
To succeed in this role, you should have:
- 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 deliver outstanding results within established timelines.
- Strong collaboration and stakeholder management skills.
- The capacity to think creatively and develop innovative solutions.
- Excellent communication and collaboration skills.
- Proficiency in English at a professional level, both written and spoken.
As our new Associate Director, you will work in a well-established and team-oriented department consisting of experienced colleagues who actively share learnings and experiences. You will collaborate closely with Danish and US colleagues across Regulatory Affairs, CMC Development, Product Supply, Quality Assurance, and global partners.
We offer flexibility in working hours and the possibility to work partly from home. Your place of work will be in our modern office facility in Tuborg Havn in Hellerup, Denmark, with a view of the harbour, canals, and sea.
Salary and BenefitsThe estimated salary for this position is approximately **DKK 950,000 - 1,100,000** per year, depending on your qualifications and experience. We also offer additional benefits, including professional development opportunities and a supportive work environment.
How to ApplyIf you are a motivated and experienced Regulatory Affairs CMC professional looking for a new challenge, please upload your CV and respond to the following questions: 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?
-
Global Regulatory Affairs Director
2 weeks ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeOverviewAt 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 SummaryWe are looking for a seasoned professional with a proven track record in regulatory affairs...
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAt 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 timeCompany 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 timeLead 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...
-
Global Medical Director External Programs Lead
2 months ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeWe 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...
-
Global Medical Director External Programs Leader
2 weeks ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAbout 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...
-
Global Medical Director External Programs
2 days ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeKey Responsibilities and RequirementsWe are seeking a seasoned Global Medical Director to lead the development and execution of external medical programs across our endocrine portfolio at an above-country level. This role requires strategic operational planning, direct complex project management, and coordination with cross-functional teams.Coordinate...
-
Pharmaceutical Product Expert
4 weeks ago
Gentofte, Gentofte Kommune, Denmark Ascendis Pharma AS Full timeJob 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...
-
Tax Reporting Specialist
3 days ago
Gentofte, Gentofte Kommune, Denmark Saxo Bank AS Full timeCopenhagen, Denmark About the Job We are seeking a highly skilled Tax Reporting Associate to join our Global Tax Reporting team at Saxo Bank A/S. As a key member of this team, you will play a vital role in helping us navigate complex regulatory requirements and ensure compliance with tax laws across various jurisdictions worldwide.The ideal candidate will...
-
Senior Drug Product Director
3 days ago
Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full timeTransformative Career OpportunityWe are seeking a seasoned professional to join our Aseptic Manufacturing Science and Technology team as a Senior Drug Product Manager.About the RoleThis dynamic position involves overseeing drug product activities, managing internal and external stakeholders, and developing strategies for life cycle management. As a key...
-
Market Intelligence Leader for Rare Diseases
1 month ago
Gentofte, Gentofte Kommune, Denmark Ascendis Pharma AS Full timeLead 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...
-
Volvo Maskin AS Seeks Visionary Leader
1 month ago
Gentofte, Gentofte Kommune, Denmark Director File Full timeTransforming the Future of Volvo Construction Equipment in NorwayWe are on an unprecedented transformation journey, driven by a commitment to sustainability and innovation. As our next Managing Director, you will play a pivotal role in shaping the future of Volvo Construction Equipment in Norway.Our industry is undergoing significant changes, and we are at...
-
Chief Executive Officer of Norwegian Operations
2 weeks ago
Gentofte, Gentofte Kommune, Denmark Director File Full timeLeadership 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...
-
Medical Product Development Specialist
1 month ago
Gentofte, Gentofte Kommune, Denmark Ascendis Pharma AS Full timeJob Summary:">We are seeking an experienced Medical Product Development Specialist to join our team at Ascendis Pharma A/S. This is a challenging and rewarding role that requires strong technical skills, attention to detail, and excellent communication abilities.">About Us:">Ascendis Pharma A/S is a fast-growing biopharmaceutical company with locations in...
-
Senior Quality Assurance Specialist
3 days ago
Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our Finished Products Manufacturing (FPM) QA team at Novo Nordisk A/S. The ideal candidate will have experience in GMP inspections, quality processes, and stakeholder management.Key ResponsibilitiesPlan, conduct, and follow up on GMP inspections in collaboration with...
-
Gentofte, Gentofte Kommune, Denmark Director File Full timeSenior 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...
-
Global Tax Reporting Expert
2 months ago
Gentofte, Gentofte Kommune, Denmark Saxo Bank AS Full timeAbout 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...
-
Chief Executive Officer Norway
2 days ago
Gentofte, Gentofte Kommune, Denmark Director File Full timeWe are seeking a visionary leader to spearhead our Norwegian operations as Chief Executive Officer.As the head of our Norwegian business, you will be responsible for driving growth, innovation, and sustainability in the region. You will lead a team of around 250 professionals and work closely with colleagues across Europe to achieve our shared goals.You will...
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Ascendis Pharma A/S in Copenhagen, Denmark. This is an exciting opportunity to be part of a dynamic biopharmaceutical company that is transforming the lives of patients.The ideal candidate will have a strong background in Quality Assurance with experience in...
-
Gentofte, Gentofte Kommune, Denmark Unique Human Capital AS Full timeAre you passionate about delivering exceptional quality and ensuring patient safety?In this role, you will be responsible for leading the quality assurance activities within the Patient Handling Division, including regulatory approvals, quality management system compliance, product quality, and process improvement.As a key member of our team, you will work...
