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Senior Regulatory Affairs Specialist

JUST ONE, on behalf of its client, a leading company in pharmaceutical products, is seeking a highly motivated:


Senior Regulatory Affairs Specialist



Responsibilities:


  • Development and implementation of a successful regulatory strategy for the EU clients.

  • Submission of new Marketing Authorization, variation and renewal applications for EU countries via MRP, DCP, 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 Regulatory Authorities.

  • 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.

  • Follow up of applications and maintenance of internal databases.

  • Monthly reporting to BD department.

  • Keeping abreast of EU pharmaceutical legislation, guidelines, and practices.

  • Participation in the training of new RA team members.

  • Coach, guide and review deliverables of RA Specialists.


Requirements:


  • Minimum of a BSc Degree in Pharmacy, Chemistry, Biology or another relevant field.

  • 5+ years of relevant experience in the pharmaceutical area.

  • Being familiar with EU regulatory guidelines.

  • Excellent communication in English language (writing & speaking).

  • Computer literacy.

  • Problem-solving and organizational skills.

  • Multi-tasking.

  • Time management.

  • Ability to prioritize work and meet deadlines.

  • Excellent communication and interpersonal skills.


Benefits:

  • Competitive salary.

  • Continuous training.

  • Career growth and development opportunities


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