Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents in CTD and eCTD format according to EU regulatory requirements (Candidate will be mainly responsible for CMC / Module 3 work)
To prepare response to regulatory deficiencies letters according to EU regulatory requirements
To collaborate with other departments/partners
To maintain lists/documents/records
Responsible for keeping Orion internal regulatory system up to date and accurate
To achieve his/her responsibilities within the agreed timescales
To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating
Other possible tasks appointed by Supervisors
Qualification & Experience
Bachelors / Masters degree in Pharmacy from a reputed College / University
3 - 6 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines.
Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities and eCTD submissions will be an added advantage.