Regulatory Affairs Manager, Pharma

Regulator Affairs Manager for International Growth Company, CPH

Macure Pharma is a young, international specialty pharma company with focus on a wide array of mature, niche hospital products. We market a diverse portfolio, primarily across Europe, and currently experience a steep growth through acquisitions of established products and launch of our own niche generics.
We are now looking for an additional RA Manager to support our RA Team of currently six highly skilled pharmacists, primarily based in Copenhagen. You will work on multiple projects with responsibility for the entire RA-process, always with great colleagues and external specialists to support you. At present we are 25 colleagues across Europe – most of us working from our HQ in Copenhagen, where this position is located. Our culture is very informal, and we cherish good sense of humor and freedom with responsibility.

The job
Your primary responsibilities will be:
• Project management of multiple regulatory projects within RA and across departments
• Developing regulatory strategies for pipeline products in collaboration with other functions/stakeholders
• Submitting and managing National, MRP and DCP procedures, primarily in Europe
• Regulatory lifecycle management of a diverse portfolio, primarily in the European countries
• Coordinate regulatory activities with external collaboration partners, CMOs and authorities

Your profile
• Master’s Degree within Life Science (M. Sc. Pharmacy or equivalent)
• Experience from working in Regulatory Affairs
• Experience in writing and reviewing CMC documentation is regarded an asset
• Profound technical knowledge and commercial understanding
• Positive and open minded, and with the drive to influence your colleagues and surroundings
• Willingness to own, lead and deliver projects with a high respect for deadlines
• Ability to work in a small, lean organization, where flexibility is key for success

Macure Pharma offers
An interesting and challenging job in a young company with short decision processes. You will get a significant degree of individual responsibility, and the freedom to structure your own day-to-day tasks in an entrepreneurial and international atmosphere with an informal and flexible work
environment. This is an opportunity for you to grow with a company and shape how RA is managed today, but also in the future. You will work in a modern and completely renovated office space with great, competent and dedicated colleagues. You will be offered an attractive compensation package according to your individual qualifications. If needed to support your work life balance, it will be possible to discuss reduced working hours.

Application
Feel free to call HR Business Partner Lotte Tolstrup at +45 40 32 97 34 for further information. Candidates are interviewed continuously, therefore please submit your application as soon as possible to job@macurepharma.com.