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Innovation
Consulting

Responsibilities

  • Contribute to regulatory activities such as pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
  • Document and track regulatory submissions and regulatory authority approval.
  • Provide on-going regulatory support to the Regulatory Affairs Specialist and to project teams to meet project objectives.

Education

M. Pharmacy

Experience

2-3 years of EU RA experience

Technical Skills

  • Compile regulatory dossiers in accordance with national requirements.
  • Provide regulatory support to clients and associate companies.
  • Preparation of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
  • Provide review of artworks.

Additional Skills

  • Having experience in working for EU regulatory market.
  • Excellent organizational and interpersonal skills.
  • Ability to work well within a team.
  • Good computer skills and the ability to learn appropriate software.
  • Fluency in English (Spoken and Written).

Regulatory Affairs Associate-886

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