Careers

We are looking for new team members!

Regulatory Affairs Officer

Responsibilities / Job description:

• Assist in compilation of National and European Union MAA (marketing authorisation applications) for new products, ensuring all submissions occur in line with project timings.
• Provide the focal point for the Czech regulatory agency for national submissions, and assist Regulatory office managers and customers with dossier submissions and deficiency assessments in other assigned territories.
• Preparation, review and completion of Module 1.3 texts and artwork for new products in multiple territories.
• Maintenance of existing marketing authorisations including renewals, variations, re-registrations and compliance issues, as requested by the Regulatory Authorities in Czech Republic. Submission of PSURs to the Czech Regulatory Authorities for local and global products.
• Translations of Regulatory, GMP and Technical and Supply Chain and Distribution issues into English, including requests from authorities and changes to local regulations.
• Monitoring of publications at official papers (if applicable) and communication to managers and customers of relevant developments.
• Direct contacts and visits with regulatory agencies, on behalf of the company and its customers as part of the overall regulatory process.

Personal / Professional Qualities Required:

• A Scientific degree qualification in Chemistry, Pharmacy, or equivalent.
• At least 2-3 years experience in Regulatory Affairs.
• Drive, scientific focus, and a strong investigative spirit.
• The ability to handle many different contacts and projects simultaneously.
• The ability to operate under pressure and achieve agreed deadlines.
• Attention to detail.
• Well developed interpersonal and communication skills in terms of personal presentations, discussion and written work.
• Fluent Czech language and a good standard of written and spoken English.
• Good PC and typing skills, familiarity with MS Office.

To apply please email your CV and a cover letter to info@pharma-eu.com

Regulatory Affairs Managers:

Qualifications and Experience:

• Minimum degree level (BSc or equivalent) qualification in Pharmacy; Chemistry, Biochemistry,
  Pharmaceutical science, or a biological/biomedical discipline;
• A higher degree (MSc, PhD) is an advantage but is not essential;
• European Qualified Person status is an advantage for more senior roles;
• Junior roles will have a minimum of 2 years Regulatory Affairs experience;
• Senior personnel will have a minimum of 5 to 10 years of regulatory affairs experience, preferably gained in a pharmaceutical or biotechnology company, a regulatory affairs consultancy or a regulatory agency;
• Experience with biotechnology products is especially valuable, as is experience with non-clinical and clinical regulatory development.

Other skills and attributes:

• Excellent spoken and written English.
• Other European languages an advantage.
• Attention to detail.
• Computer literate (familiar with MS Office Suite, Word, Excel, Powerpoint, Project and Adobe Acrobat etc) and use of the internet as a resource.
• A resource flexible, hands-on approach to all activities.
• Time management skills.
• Project co-ordination /project management skills.
• Team oriented.
• Personable, knowledgeable, tactful, good at liaising and communicating with others at all levels.
• Commercially aware.

To apply please email your CV and a cover letter to info@pharma-eu.com

Preferred Readability Testing Providers for: