regulatory affairs officer

Genepharm SA, a Leading European Generic Pharmaceutical Company, with
an impressive international customer base, seeks a new candidate for the:

Regulatory Affairs Department

 (REF: RA/25)

The position resides within the Regulatory Affairs Department and it involves new and marketed products support as it pertains mainly to writing, compiling, and maintenance of the administrative, quality and technical sections.

The candidate is expected to remain current with regards to regulations, guidelines and policies for the pharmaceutical/manufacturing areas and to assist in interpreting and advising on the complex and evolving regulatory requirements.

Major responsibilities include, but are not limited to, the following:

• coordinating, compiling and reviewing CMC (quality) data package for appropriate and complete documentation

• communicating with internal and external parties to obtain required supporting documents data for compilation of the CTD dossier, supplements/variations, responses to authorities’ questions etc., maintaining timelines of projects

• may provide regulatory / CMC expertise during negotiations and interactions with regulatory agencies

The applicant should have/be:

• at least Bachelor’s degree in Pharmacy, Chemistry or related scientific discipline preferable with minimum 3 years Regulatory Experience in similar position or in R&D department

• excellent knowledge of English both written and oral

• able to handle multiple tasks/projects, meeting deadlines