We have vacancy for Global Regulatory Expert role in Regulatory Affairs team. We are looking for Specialist/Sr. Specialist. This individual will be based in Mumbai/ Hyderabad. The candidate has the possibility to utilize his/her own strengths with the support of the specialists.
Responsibilities
Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents and submissions according to EU regulatory requirements.
To identify and classify the changes as per EU regulatory variation guidance.
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
Our expectations
Essential competences, education and way of working
7 - 12 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.
Fluency in oral and written English
Ability to work well independently as well as in a team setting
Task oriented with learning attitude and Team work skills
Familiarity with Microsoft Office
Qualification
Bachelors / Master degree in Pharmacy or Chemistry from a reputed College / University
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