Description
Principle Responsibilities include:Principal responsibilities may vary:
Part 1:
* Conduct content accuracy checks of labelling documents.
* Conduct template adherence checks, consistency checks and copy editing as outlined in checklists by document type.
* Conduct and/or coordinate QC of labelling documents for submission and technical compliance.
* Update and drive improvements to labelling document templates and checklists as requirements evolve.
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Part 2:
* Co-ordinate translation of EU Product Information (EUPI).
* Maintain master list of the Marketing Authorization Holder (MAH) contact details.
* Co-ordinate translation of International labelling documents: Standard Export Package Insert (SEPI), Standard Export Pack (SEP), International Package Insert, International Pack (IPI, IP). * Escalate issues relating to non compliance to senior regional and global regulatory representatives.
* Familiarity with Local Operating Company norms.
KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:
* Familiarity with labeling submission types and their required guidances.
* Ability to identify and understand complex problems and recommend common, effective compliant solutions within a global organization is a requirement.
* Able to work within a matrix environment independently to ensure deliverables and timelines are met.
* Able to work across global environments successfully is a requirement.
* A bachelor degree with 8 years of related experience is required OR 10+ years equivalent work experience with no degree is required.
* 5+yrs pharmaceutical or regulatory experience required.
* Regulatory submissions experience is preferred.
* Incumbent will have minimum one year experience in one of the Global Regulatory Affairs, Labeling & Submissions Management areas, including one of the following: Global Labeling Centre of Excellence (GLCoE), Quality Management (QM), Regulatory Data and Information (RDI), Regulatory Dossier Solutions (RDS), Regulatory Strategic Coordination (RSC) is a requirement.
* Coordination/Project management experience is a plus.
* LEAN thinking and/or Change Agent training a plus.
* Excellent proven oral and written skills are required.
* Must have strong command of English language.
* Ability to communicate at all levels of the organization.
To apply : Please contact Mina Ranavaya at Real Pharma on
To find out more about Real please visit www.realstaffing.com