Gentofte Municipality, Capital Region of Denmark, Denmark · On-site
Senior+$1.9B raised
Are you passionate about finding new pathways for approval of combination products? Do you have experience within clinical and non-clinical global regulatory affairs? If so, now is your chance to join Ascendis Pharma as …
Skills: Global regulatory strategy, Regulatory submissions, Health authority interactions, Clinical development, Non-clinical development
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Gentofte Municipality, Capital Region of Denmark, Denmark · On-site
Entry level$1.9B raised
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Gentofte Municipality, Capital Region of Denmark, Denmark · On-site
Mid level$1.9B raised
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Gentofte Municipality, Capital Region of Denmark, Denmark · On-site
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Gentofte Municipality, Capital Region of Denmark, Denmark · On-site
Senior$1.9B raised
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Medical Assessment and Signal Detection Lead (MD) GPS Medical Science- ID:2006b
Princeton, New Jersey, United States · Hybrid
$220k–$235k/yr
Senior$1.9B raised
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at As…
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Medical Assessment and Signal Detection Lead (MD) GPS Medical Science- ID:2006b
Palo Alto, California, United States · Hybrid
$220k–$235k/yr
Senior$1.9B raised
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at As…
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AD, Medical Assessment and Signal Detection Lead, GPS Medical Science - ID: 2006
Palo Alto, California, United States · Hybrid
$220k–$235k/yr
Senior$1.9B raised
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at As…
Skills: Medical assessment, Signal detection, Pharmacovigilance, ICSR review, Regulatory compliance
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Princeton, New Jersey, United States · Hybrid
$220k–$235k/yr
Senior$1.9B raised
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Gentofte Municipality, Capital Region of Denmark, Denmark · On-site
Mid level$1.9B raised
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Associate Director, Program Safety Lead - Job ID: 1908b
Palo Alto, California, United States · Hybrid
$200k–$215k/yr
Senior$1.9B raised
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Associate Director, Program Safety Lead (MD) - Job ID: 1908
Palo Alto, California, United States · Hybrid
$220k–$235k/yr
Senior$1.9B raised
Are you passionate about patient safety and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced Program Safety Lead to champion safety excellence, drive compl…
Skills: Pharmacovigilance, Signal Detection, Risk Management, Safety Surveillance, Endocrinology
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Gentofte Municipality, Capital Region of Denmark, Denmark · On-site
Mid level$1.9B raised
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Princeton, New Jersey, United States · Hybrid
$210k–$225k/yr
Senior+$1.9B raised
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Gentofte Municipality, Capital Region of Denmark, Denmark · On-site
Entry level$1.9B raised
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Princeton, New Jersey, United States · Hybrid
$190k–$205k/yr
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Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at As…
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Gentofte Municipality, Capital Region of Denmark, Denmark · On-site
Mid level$1.9B raised
Are you passionate about maximizing the value of IT systems, enabling better business decisions, and improving daily processes? Do you have experience gathering requirements, translating them into system configurations, …
Skills: Requirements Gathering, User Stories, Agile Methodology, System Configuration, Technical Documentation
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Full-time
postgraduate degree
Posted 2h ago
~40 hrs/week
Responsibilities
Develop and execute global regulatory strategies while leading the preparation and delivery of regulatory submissions. Provide strategic guidance on clinical and non-clinical development activities and represent the company in health authority interactions.
Requirements
Requires a master's degree and at least 10 years of experience in global regulatory affairs. Candidates must demonstrate expertise in regulatory strategy, submissions, and possess strong stakeholder management skills.
Full job description
Are you passionate about finding new pathways for approval of combination products? Do you have experience within clinical and non-clinical global regulatory affairs?
If so, now is your chance to join Ascendis Pharma as our new Associate Director.
Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.
At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease portfolio. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.
We are seeking a passionate Associate Director to join our growing team. As a key member of the team, you will play a crucial role in strategic decisions and support regulatory approvals as well as development and life cycle management. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.
You will be joining the RA Clinical Strategy team in Denmark consisting of 10 colleagues, and report to Mette Schou-Hanssenwho is based in our Hellerup office, where you will also be based.
Your key responsibilities will be:
Develop and execute global regulatory strategies in partnership with cross-functional teams to support product development and regulatory approvals.
Lead the planning, preparation, review, and delivery of regulatory submissions, ensuring compliance with global regulatory requirements.
Provide strategic regulatory guidance on clinical and nonclinical development activities, including risk assessment and issue management.
Monitor and interpret evolving regulatory requirements, trends, and guidance, translating these into actionable recommendations for project teams.
Represent Regulatory Affairs in cross-functional teams and health authority interactions, supporting negotiations and driving science-based regulatory decisions.
Contribute to key development initiatives, including scientific advice, orphan drug designations, pediatric development plans, and change control assessments.
Develop and maintain regulatory documentation and product information in accordance with applicable regulations.
Drive continuous improvement of regulatory processes, promote knowledge sharing, and build strong relationships with internal and external stakeholders.
Qualifications and Skills:
You hold a relevant academic degree – preferably a master’s degree of science – and 10 years of experience within global regulatory affairs.
Furthermore, you have:
Demonstrated expertise in global regulatory strategy, submissions, and health authority interactions.
Solid understanding of clinical and nonclinical development requirements and applicable global regulations.
Excellent communication, influencing, and stakeholder management skills.
Ability to work independently, manage competing priorities, and deliver results in a complex global environment.
Key competencies:
You are a strong team player, analytical, and have a can-do attitude.
You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.
To succeed in this role, we also expect you to have a strategic mindset with strong problem-solving, decision-making, and risk management capabilities.
Travel: 15 days per year.
Office: Tuborg Boulevard 12, Hellerup
Apply now.
We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.
To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated.
For more details about the position or the company, please contact Mette Schou-Hanssen, [email protected].
You can learn more about Ascendis by visiting our website www.ascendispharma.com
Applications must be submitted in English and will be treated confidentially.
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs, your ownership of these candidates will not be acknowledged.
Committed to making a meaningful difference for patients
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Founded
2007
Headquarters
Hellerup, Capital Region of Denmark
LinkedIn followers
113,134
Total funding
$1.9B
Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.
Offices: Tuborg Boulevard 12, Hellerup, Capital Region of Denmark 2900, DK
Committed to making a meaningful difference for patients
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Founded
2007
Headquarters
Hellerup, Capital Region of Denmark
LinkedIn followers
113,134
Total funding
$1.9B
Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.
Offices: Tuborg Boulevard 12, Hellerup, Capital Region of Denmark 2900, DK