We are looking for a successful Drug Regulatory Specialist. You are someone who will be able to work cross-functionally within an experienced team to drive the success of team work.
Responsibilities of the Drug Regulatory Specialist:
Timely preparation of registration dossiers for new registration, renewals and all types of variations to a marketing authorization, adapting of analytical and normative documents, technological documents, leaflets. Submission to Health authorities of all registration documents and monitoring the registration process in order to obtain regulatory approval in due time.
Timely preparation and submission to logistic department and person, responsible for quality of the necessary Ukrainian documentations for local GMP approval Roche’s manufacturing sites. Ensuring the regulatory consulting support.
To keep updated the Product Registration Database and provide Roche Ukraine stakeholders with data on the registration status of all company products.
To ensure Competitive Intelligence data on the registration status when necessary.
To provide General Manager and Medical Director with relevant information on current changes in regulatory legislation, provide advice and, if necessary recommendations, on implication of these changes on Roche Ukraine operational activity.
Reply to requests from HQ and local regulatory authorities, preparing the reports and recommendations if necessary.
Who you are:
· You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.
Requirements for the position of the Drug Regulatory Specialist:
· University degree in pharma or medical would be preferable
· Experience in drug regulatory area from 1 year
· Balanced ambition. Eagerness to professional growth within the Company
· Excellent verbal and written communication skills
· Demonstrated ability to act independently, to meet deadlines
· English upper-intermediate
What we offer:
Roche offers an attractive opportunity for personal and professional development in an international successful company. The compensation and benefits package offered is attractive and competitive.