Regulatory Affairs Manager

Regulatory Affairs Manager

Regulatory Affairs Manager

Do you want to be an important part of a fast-growing international pharmaceutical company with dedicated people and a strong entrepreneurial spirit? Join our small team and become part of our regulatory voice both internally and externally.

The job:

You will be a key part of our Regulatory Affairs & Quality Assurance team.
Your primary responsibilities will be:
• Developing regulatory strategies for pipeline products with the management
• Submitting and managing National, MRP and DCP procedures in Northern Europe
• Regulatory lifecycle management of existing MAs in all our Northern European countries – SPCs, PILs, preparing and submitting applicable variations
• Coordinate regulatory activities with our external collaboration’s partners, CMOs & the competent authorities

When & Where: Full time. Office based in Copenhagen NV.

Your profile:

• You hold a master’s degree within Life Science (M. Sc. Pharmacy or equivalent)
• You have solid experience in Regulatory Affairs
• You have a profound technical knowledge and commercial understanding
• Positive and open mindset, as well as a drive to influence your colleagues and surroundings
• A 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

We offer:

An interesting and challenging job in a young, growth company with short decision processes. You will have a significant amount of individual responsibility, and the freedom to structure your own day-to-day tasks – all in an international, entrepreneurial atmosphere with an informal and flexible work environment. This is an opportunity for you to grow with the company, and shape how our RA is managed today, but also in the future. This will all be done in our modern and completely renovated office space with great colleagues. You will be offered an attractive compensation package according to your individual qualifications.
Application: This position was posted in May 2020. There is no application deadline, but we will interview candidates continuously and close the position down once we have found the right candidate. Therefore, we kindly ask you to submit your application as soon as possible. Please forward to info@macurepharma.com.

Further information: In case of any questions, please feel free to reach out to Managing Director Mads Renlef Henningsen – mrh@macurepharma.com
or tel. no. : +45 51 92 99 32

Who is Macure Pharma:

Macure Pharma is a small, international specialty pharma company with focus on mature, niche hospital products. We market and sell a diverse product portfolio across the Northern European countries, and currently we have several products in procedure with relevant authorities.
Our principal focus is late stage pharmaceuticals, and we grow through acquisitions of established products, and through launch of our own niche generics.
We believe in trust and integrity in all aspects of our business. We strive for the highest level of quality and act responsible in all our activities reflecting a high ethical standard. We value honesty and mutual respect and recognize that our success depends on a good internal working environment.
We are currently 15 colleagues at Macure Pharma.

For more details of Macure Pharma, please see our company profile – www.macurepharma.com/company/