Regulatory Affairs Officer

2 weeks ago

Chalandri, Attica, Greece Creative Pharma & HR Services Full time €35,000 - €45,000 per year

The position assists the Regulatory Affairs team, to ensure the timely delivery of high-quality services, according to the Standard Operation Procedures, GXPs and applicable regulatory requirements.

MAIN RESPONSIBILITIES

  • Assist and liaise Regulatory Affairs team with regulatory activities according to assigned project/s.
  • Preparation of submission or reporting documentation, as assigned.
  • Contribute to the preparation of e-CTD sequencies, as assigned.
  • Preparation of any other regulatory documentation required for Food Supplements, Biocides, Medical Devices, Cosmetics, as assigned.
  • Translation of Product Information (SPC, PIL, Labeling) and any other Regulatory document from the English to Greek language and vice versa.
  • Support artwork review and labels proof reading activities, in compliance with Client and regulatory requirements.
  • Assist during preparation, maintenance and update of procedures and work instructions related to regulatory affairs department and maintain the department's records and archives.
  • Keep up to date with changes to current regulations and stay abreast of new regulations affecting regulatory activities.
  • Maintain adequate knowledge and comply with data privacy requirements, with the support of the QA&IS department and the DPO.
  • Comply with all Policies, Standards, Procedures, Instructions, and requirements of the Company's Quality and Information Security Management System; Perform all related duties as assigned; Contribute to team effort by accomplishing related results, as needed.

REQUIREMENTS

  • University Degree in Life Sciences, Pharmacy, Biology, Chemistry, or related field is required
  • 1-2 years of previous work experience in Regulatory Affairs including National, European and/or RoW submissions.
  • Good working knowledge of EMA, EOF and ICH guidelines
  • Excellent Computer skills (including word processing, spreadsheet, and database management applications)
  • Fluency in the written & spoken English language
  • Excellent interpersonal, written and verbal communication skills in both English and Greek.
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail
  • Willingness to work in a matrix environment and to value the importance of teamwork.
  • Strong customer service-oriented approach

WHAT WE OFFER

Creative Pharma & HR Services is offering a competitive remuneration package according to the Industry's standards. Nonetheless, we are also proud at Creative Pharma & HR Services that we are an open and learning organization that fosters a collaborative, enthusiastic, fast paced working environment, and for that reason we invest in people's potential and growth.

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