regulatory affairs submissions senior officer.

The company offers to the Regulatory Affairs Submissions Senior Officer:

• Competitive remuneration package.
• Positive and inspiring working environment
• Opportunities for personal and professional development.

As a Regulatory Affairs Submissions Senior Officer, some of your tasks will include:

• Planning and execution of National, DCP or MRP regulatory procedures, according to global legislation and national guidelines, in line with assigned timelines
• Collect, prepare and 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 linked to 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)
• Submission of eCTD dossier and relevant packages via specialized Common European Submission Portal (CESP) where applicable
• RA database maintenance for designated projects

The requirements for the Regulatory Affairs Submissions Senior Officer position are:

• University Degree in Life sciences e.g. Pharmacy, Biology, Chemistry etc, or relevant field (M.Sc. will be considered an asset)
• At least 3 years experience in Regulatory Affairs
• Good knowledge of regulations, guidelines and procedures relevant to pharmaceutical product registration
• Working knowledge of current guidelines for CTD dossier preparation and maintenance
• Excellent command of English language, both verbally and written
• PC literacy (MS Office skills)
• Organizational, planning and problem-solving skills
• Effective cross-functional communication
• Team working 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 under specific deadlines

At least 3 years’ experience in Regulatory Affairs

If this sounds like you, we want to hear from you today! Should you need additional information,  please contact me Vasia Christodoulou at 6941411215Please note that for transparency and equity reasons, only those applications made online via our site will be assessed. After the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. ​ All applications are considered strictly confidential.