Position in Regulatory Affairs.

Publicerad:
2019-04-12
Omfattning:
Heltid
Kontakt:
Emelie Lanner
Telefonnummer:
072-9733382

Detaljer

Publicerad:
2019-04-12
Ort:
Malmö, Skåne län
Kategori:
Life Science
Specialisering:
Läkemedel, bioteknik & medicinteknik
Omfattning:
Heltid
Referensnummer:
201214105
Sista ansökningsdag:
2019-05-06
Kontakt:
Emelie Lanner
Telefonnummer:
072-9733382

Beskrivning

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 working in or 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. PolyPeptide Group is a growing company on the international arena.

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. You will be a member of the RA team with seven colleagues, one Regulatory Affairs assistant, five Regulatory Affairs Managers and the Global Director.

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 Regulatory Affairs Global Director. This role involves many contact areas. Internally, you work closely with both global and local functions within R&D, QA, QC and Sales & Marketing. You will have a lot of 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. You will work with some of the Big Pharma companies being PolyPeptide’s customers.

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 project team
Qualifications:

  • Minimum a bachelor's degree in chemistry / pharmacy
  • Minimum 10 years work experience in RA / QC / QA or in the field of chemical synthesis-, pharmaceutical- or process development in the pharmaceutical industry
  • High ability to write chemical and technical texts
  • Fluent in English, both spoken and written
  • Understanding of Regulatory Affairs work
  • Mind for customer service
To be successful in this role we believe that you are a structured and analytical person with a high sense of responsibility who looks for ways to improve and promote. You will have several individual tasks, which means that you spend a lot of time working in our digital environment by yourself but you are also an effective team player that can help the team to achieve its objectives.

You spread energy among your colleagues and you have excellent communicative skills. As a person you are flexible and you are able to shift focus quickly. You are skilled at analyzing complex situations or data and you know when to go into the details since that is an important part of your work.

Company: PolyPeptide Group

Location: Limhamn, Malmö

Job type: Permanent position

Last day for applications: 2019-05-06, selection is on-going

More information: This recruitment will be managed by Dfind Science & Engineering. For more information about this position please contact Recruitment Consultant Emelie Lanner 072-973 33 82 or emelie.lanner@dfind.se. Please send your application via https://www.dfind.se/science-engineering/

We look forward to your application!

About PolyPeptide Group:
The PolyPeptide Group is a contract manufacturing organization for peptides and peptide related molecules.  A global presence throughout the world assures our clients a reliable supply with the necessary capacity for an uninterrupted service. The Group is one of the world’s largest independent contract manufacturers of therapeutic peptides for the pharmaceutical market employing more than 800 people in six manufacturing sites located in France, India, Belgium, Sweden and the USA.

PolyPeptide Group is privately-held organization that manufactures over one third of all approved peptide drug substances (22 of 62 approved products worldwide) accounting for over 25% of the sales of outsourced peptide therapeutics worldwide.

Get a first glimpse of your new place of employment here Movie PolyPeptide Group

For more information, go to our website

Search words: Regulatory Affairs Manager, RA, CMC, pharmaceutical industry, regulatory documentation, PolyPeptide Group