Sr. Regulatory Associate, Russia and Eurasian Economic Union (EAEU).
Fixed Term Contractor. Reporting to the Regulatory head of Russia.
Specific Responsibilities :
Represent Regulatory Affairs on internal and external cross-functional teams (e.g., RST), providing regulatory affairs support and strategy for investigational and / or marketed products, as assigned.
Responsible for new product registration submissions, GMP inspections applications submissions for assigned products, renewals, post-
approval variations, localization projects.
Liaise with Pharmacovigilance and Epidemiology (PVE) and International Regulatory Affairs regarding submission of DSUR, PSUR / PBRER, urgent safety restrictions and safety variations.
Obtain and maintain necessary regulatory-associated licences and obligations with Russia and EAEU agencies in order to allow company to conduct its business.
Potential opportunity to compile and submit new clinical trial applications.
Submission and coordination of distribution of Dear Healthcare Provider Letters.
Provision of accurate English translations of all agencies correspondence and labelling for company’s products in Russia and EAEU.
Work within the department and with other functional areas on process improvements.
Acts as deputy responsible person for pharmacovigilance (Deputy PRP) in Russia and EAEU.
Regulatory Affairs :
Responsible for preparing regulatory submissions which require cross-function interactions with internal and external partners (as appropriate) for investigational and commercial products for Russia and EAEU in line with local and international requirements and company policies and procedures.
Responsible for new product registration and GMP applications submissions for assigned products, which may include routine submissions (e.
g., safety reports, DSUR, PSUR / PBRER, and Registration Renewal) as well as post approval variations and labeling updates, as needed.
Contribute to preparation and filing of new registrations or CTA submissions, as required.
Provides regulatory support to development and / or revision of product labeling (e.g., local labeling) in accordance with Russian and EAEU requirements and in alignment with company policies and standards.
Participate in team meetings whenever required for assigned products; responsible for development of regulatory strategy and presentation of ongoing project updates.
Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge.
Initiates or contribute to local process improvements, which have an impact on the working of the Regulatory Affairs function or other departments.
Deputy PRP - Pharmacovigilance
The deputy Pharmacovigilance Responsible Person with the PRP are responsible for :
Managing all aspects of local Individual Case Safety Report (ICSR) Management : receipt, follow up from all sources including screening of local literature.
Maintaining local knowledge in relation to safety activities such as the Gilead Pharmacovigilance organization, local Regulatory Authority contacts and local Pharmacovigilance regulatory requirements (and communicating changes in requirements to PVE ), specifically for submission of safety reports and creation of local Pharmacovigilance plans.
Serving as the deputy point of contact within the Affiliate for safety related training activities, safety related enquiries / support or local Regulatory Authority inspections relating to Pharmacovigilance.
Being a proactive member of the Gilead PRP Network.
Knowledge, Experience and Skills :
Pharmacist. Biotechnology. Pharmacist or Chemist. Experience in Biotechnology will be an advantage.
Minimum 5 years of relevant experience in Regulatory Affairs or related field.
Excellent organizational, communication and interpersonal skills.
Ability to work independently on multiple projects with tight timelines is required. General understanding of regulatory requirements, including ICH requirements, Russian and EAEU requirements for assigned territories.
Is recognized as a knowledgeable resource within the department on limited topics.
Work is performed under minimal supervision of a Regulatory Affairs professional.
Fluent in English both verbal and written, Russian native.