Regulatory Affairs Senior Officer

2 weeks ago

Kifissia, Attica, Greece ANFARM Full time €40,000 - €60,000 per year

ANFARM Hellas SA,
an
EU GMP Pharmaceuticals Manufacturer
, is a highly reputable manufacturer of
generic pharmaceuticals
with an extended export activity worldwide.

ANFARM Hellas SA
is looking for

REGULATORY AFFAIRS SENIOR OFFICER

with accountability for managing and executing the full RA life cycle across multiple simultaneous projects as well as alliance management.

Main duties and responsibilities:

  • Planning and execution of National, DCP or MRP regulatory procedures, according to EU legislation and global national guidelines.
  • Collect, prepare, compile regulatory documentation, for the product's full lifecycle maintenance (initial Marketing Authorization, variations, and renewal procedures).
  • Communication with Health Authorities and partners for the successful registration of products.
  • Liaise with various departments for the collection, preparation, review, and compilation of regulatory documentation.
  • Handling of responses to DL's liked initial submissions, variations, or renewals.
  • Preparation of m1 of the CTD dossier and compilation of modules 1-5 of the eCTD dossier (using specific eCTD software), where applicable.
  • Submission of eCTD dossier and relevant packages via specialized Common European Submission Portal (CESP), where applicable.
  • RA database maintenance for designated projects.

Qualifications/Requirements:

  • University Degree in Life Sciences e.g. Pharmacy, Biology, Chemistry etc. (M.Sc. will be considered an asset).
  • At least 4 years of experience in Global Regulatory Affairs.
  • Good knowledge of global regulations, guidelines, and procedures relevant to pharmaceutical product registration.
  • Working knowledge of current guidelines for CTD dossier preparation and maintenance.
  • Good command of eCTD software.
  • Excellent command of English language, both verbally and written.
  • PC skills (MS office etc.).
  • Organizational, planning, and problem-solving skills.
  • Effective cross-functional communication.
  • Teamworking spirit, capable of handling tasks efficiently and under minimal supervision.
  • Ability to work equally well independently or as a member of a team.
  • Ability to deliver high quality work in a timely manner and to specific deadlines.

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