RA Manager

Position in Regulatory Affairs

Have you been working within the Pharmaceutical industry for some time and are you now ready for the next step in your career? Are you interested in Regulatory Affairs? Then, here is an opportunity for you! PolyPeptide Group is now searching for a driven person that wants to develop in the field of CMC and Regulatory Affairs.

We are searching for someone with a “can do” attitude and a problem solving mindset who is looking for a dynamic workplace with dedicated colleagues. This is an opportunity to develop in a role that comes with responsibility and where you can make a difference. Regulatory Affairs is a key function of the PolyPeptide Group with the department in Limhamn as the central unit.

Job description:

In the position, you will have regulatory responsibility for a number of pharmaceutical drug substances included in our global product portfolio. This means, among other things, writing, compiling and updating registration documentation such as Drug Master Files and CEP applications. You become part of a Regulatory Affairs team that has great experience and expertise and you report to our Head of Regulatory Affairs, Sweden. This role involves many contact areas. Internally, you work closely with both global and local functions within R&D, QA, QC and Sales & Marketing and you will represent Regulatory Affairs in the project teams. You will also have contact with your colleagues at the other PolyPeptide sites, especially in Belgium and India. Externally, you work with customers and regulatory authorities around the world.

Key duties and responsibilities include:

-Writing regulatory documentation

-Correspondence with customers regarding regulatory documentation and strategies as well as technical issues

-Communicating with regulatory authorities globally

-Represent Regulatory Affairs in the project teams

Qualifications:

- Minimum a bachelor's degree in chemistry / pharmacy
- Several years' experience of RA / QC / QA or in the field of chemical synthesis-, pharmaceutical- or process development in the pharmaceutical industry
- High ability to write, compile and review chemical and technical texts
- Fluent in English, both spoken and written
- Understanding of Regulatory Affairs work
- Service minded


We believe that you are experienced and confident in your regulatory affairs skills and wish to continue developing and contributing to customers and colleagues.

To be successful in this role, you are self-driven and flexible with the ability to structure your work, shift focus quickly and manage multiple requests while maintaining quality and timelines. You have a high sense of responsibility and looks for ways to improve and promote. You have also a high ability to work independently as well as you are an effective team player that spread energy among your colleagues and help the team to achieve its objectives. You have clear and timely communication skills, both in speaking and writing. You are an analytical person with a good sense of details and skilled at analyzing complex situations.

Application

PolyPeptide is collaborating with DEDENROTH about this recruitment, so please contact Mia Danielsen at md@dedenroth-consulting.com / +4526178142 if you are interested in the position or if you have any questions.