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Senior Director, Global Regulatory Lead

Join an entrepreneurial and fast-growing company where skilled, agile and highly resourceful professionals can truly make their mark.

 

Ascendis Pharma offers a dynamic place for employees to grow and develop their skills, while influencing the direction of this global company.

As Senior Director, Global Regulatory Lead you will be a key member of the Regulatory Affairs team and the Regulatory Affairs management team, and report directly to the Vice President, Regulatory Affairs.

Your main tasks are:

  • Global regulatory strategy: Proactively develop and provide regulatory guidance and strategies for optimal drug development and marketing authorizations globally. Collaborate with cross functional peers to facilitate and optimize the product development and registration process
  • Clinical trials: Conduct and supervise regulatory activities and submissions relating to the successful execution of clinical trials
  • Regulatory submissions: Lead, as directed and required, regulatory communications with and submissions to such as orphan drug applications, PIPs/PSPs, health authority advice, marketing applications and life-cycle management submissions on assigned development projects
  • Regulatory intelligence and policies: Contribute to establishing and administering internal regulatory policies and procedures to achieve best practices work processes. Stay abreast of newly issued regulatory laws and guidances to promptly identify possible impact or improvement to product programs. Participate in professional and industry organizations to follow regulatory trends
  • Line management: Lead and supervise direct reports to perform assigned job tasks. Mentor and coach direct reports to perform optimally in their current role. Develop direct reports to the next level

Your qualifications include as a minimum 10 years of documented professional experience from a Regulatory Affairs position from a pharmaceutical/biotechnology company developing biologics or synthetic peptides. You must have extensive regulatory experience including IND/CTA, NDA/BLA/MAA, lifecycle management, labelling, interactions with Health Authorities, and experience in developing short- and long-term regulatory strategies to rapidly deliver innovative products to the market. Finally, the candidate must have demonstrated an ability to collaborate effectively with multiple functions, including Research, Development, Clinical, Commercial, and Quality.

You have a relevant Master’s Degree within Life Science and you have experience working as a RA project lead of BLA and/or NDA filings. Further, you have a strong understanding of clinical development and how to present clinial data to FDA. In addtion, you must have experience with labelling development and with the close collaboration with marketing and market access.

Preferably, you have experience in working with a combination product.

You are a person who thrives on being challenged and working in collaborative environments.  Strong interpersonal skills are necessary, as you will serve as a major contributor and trusted member of the project development teams. A proven ability to communicate with other development staff in a fast-paced environment is crucial. Finally, an ability to think and manage strategically with attention to detail is needed, as is a high energy level, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance their exciting product pipeline and get the first product on the market.

Travelling: 30-40 days per year.

Domicile: Ascendis Pharma resides in Tuborg Havn, Hellerup.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M +45 21 75 19 25 or Senior Research Consultant, Anne Thomsen, Unique Human Capital on M: +45 31 40 01 11. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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