Main duties & key responsibilities:

  • Submission of new Marketing Authorization, variation and renewal applications for EU countries via MRP, DCP, CP, NP in eCTD format using relevant eCTD software.
  • Preparation of Module 1 documentation (including Product Information) for all above-mentioned applications and responses to Deficiency Letters (DLs).
  • Liaise closely with EU and local Regulatory Authorities to facilitate approvals and address queries.
  • Collaboration with internal and external parties and customers and coordination of all activities required for collection of all necessary information and documentation for compilation of Module 1 and responses to DLs.
  • Participation in teleconferences and meetings with the Regulatory Authorities, suppliers, clients.
  • Keeping abreast of EU and local pharmaceutical legislation, guidelines, and practices.
  • Maintenance of internal RA databases.

Requirements:

  • Minimum of a BSc Degree in Pharmacy, Chemistry, Biology or another relevant field.
  • 3+ years of relevant experience in the pharmaceutical sector.
  • Familiarity with EU regulatory frameworks and guidelines pertaining to the registration of pharmaceutical products.
  • Excellent communication in English language (writing & speaking).
  • Computer literacy (Word, Excel, PowerPoint, etc).
  • Strong planning, problem-solving and organizational skills.
  • Multi-tasking and effective time management to ensure project deadlines are met.
  • Ability to work collaboratively in a team.
  • Highly developed attention to detail.
  • Excellent communication and interpersonal skills.

Benefits:

  • Competitive salary.
  • Continuous training.
  • Career growth and development opportunities.

To apply, kindly submit your CV at HR@PharmaPath.eu referencing the code RAS/02.

Based on your consent all received applications will be stored in our database for a maximum period of 6 months and all data will be treated with strict confidentiality commensurate to data protection regulation.

 

Application Form