Professional for Regulatory Affairs CMC

Are you passionate about supporting regulatory activities? Do you want to work globally in an innovative company making our products available for patients worldwide?

If so, now is your chance to join Ascendis Pharma as our new Professional for Regulatory Affairs CMC.

Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives.

Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.

We are seeking a passionate Professional to join our Regulatory Affairs CMC team. As a key member of the Ascendis Pharma team, you will play a crucial role in supporting the life cycle stage of our portfolio and second line regulatory approvals. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams and working together to achieve extraordinary results.

You will be joining an experienced, well-established, and team-oriented Regulatory Affairs CMC department, which consists of ten colleagues, who is known for supporting each other by actively sharing learnings and experience.

You will be working closely together with Danish and US colleagues across Regulatory Affairs, Product Supply, Quality Assurance, and our global partners. Daily, you will have many internal and external stakeholder interactions.

You will report directly to Bente Brunbakke, Senior Director of Regulatory Affairs CMC. Bente is based in Hellerup, Denmark. You will be located in Hellerup as well.

Your key responsibilities will be:

• Supporting regulatory activities according to Ascendis business strategy and within agreed timelines and for specific deliverables such as:
• Coordination and submission of regulatory applications for products with marketing authorisations.
• Support to the submission, and approval of marketing authorisation applications in new countries worldwide.
• Collaboration and alignment within Regulatory Affairs during planning of our submissions.

Qualifications and Skills:

For this specific role the right candidate can look in many ways.

You might be a graduate with a few years of experience or an interest in Regulatory Affairs who wants to learn, or maybe you come with more seniority and a proven record of regulatory experience.

You hold a master’s degree, bachelor’s degree, or similar relevant education. You are proficient in English at a professional level, both written and spoken.

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

Key personal competencies:

We expect you:

• To be a strong team player, analytical, and have a can-do attitude.
• To possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.
• To be proactive and highly committed to deliver excellent results within the established timelines.

Place of work: Ascendis Pharma headquarters is in a modern and bright office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.

Apply now

If you are excited about the role and passionate about joining a dynamic company dedicated to bringing new therapies to improve patients’ lives, we encourage you to apply.

You apply for the position by uploading your CV and answering a few questions in the formular.

You do not need to attach a cover letter.

Applications will be evaluated when received, so please apply as soon as possible.

All applications must be submitted in English and are treated confidentially.

For more details about this position please send an e-mail to [email protected]

Benefits

• You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.
• Laptop, iPhone, paid internet, and home office equipment
• A thorough and structured onboarding program
• To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development. If a need is identified, we find a way to help you grow.
• Soft drinks, fresh fruit and a wide variety of snacks every day, no strings attached.
• To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.