Supports the activities of the affiliate’s Regulatory Affairs team with local Regulatory Authorities and other stakeholders to ensure that the company complies with country’s / ies applicable legislations and regulations pertaining to our portfolio (at all stages of the product’s life cycle) i.
e. ensure that Gilead medicinal products can be
maintained on the market
Essential Duties and Responsibilities
Core Technical Regulatory Contributions
Interaction with Local Health Authorities (HA)
Support the interaction and communication with the local HAs :
Works proactively to build and maintain contacts with relevant local HA personnel at own level.
Support interactions with other departments / functions for response to local HAs.
Support for incidents involving regulatory matters (as required).
Support the management of relevant local HA inspections.
Prepare regulatory (submission) documentation with direct supervision from more senior associates regardingDear Healthcare Provider Communications submissions and follow-
up until approval.Risk Minimization Measures submissions and follow-up until approval.
Prepares regulatory submission documentation with direct supervision from more senior regulatory personnel in order that all regulatory submissions to local HAs are done in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects.
Main types of submissions are (not-exhaustive) :
Clinical trials applications, amendments and other clinical trials submissions.
Marketing Authorisation (MA) applications.
Variations and other MA maintenance applications.
Risk Minimization Activities materials.
Dear Health Care Professional communication.
Compliance with the Relevant Laws and Regulations that Relate to the Core Activities of Regulatory Affairs in Gilead
Support to ensure compliance with local law and regulation and consistency with global procedural documents.
Contribute as requested to the creation, maintenance, training, evaluation and tracking of all local regulatory owned procedural documents including policies, SOPs, manuals and working instructions that are needed locally to fulfill regulatory obligations including but not limited to those in the scope of GMP / GDP, GPvP and GCP for assigned product(s) or projects.
Support the activities needed to manage Regulatory Compliance audit within the affiliate.
Support the activities needed to ensure compliant labeling for Gilead medicinal products in the country (SmPC, PIL, packaging) and manage timely updates for assigned product(s).
Knowledge of the main sources of Regulatory intelligence and the Affiliate role in rapidly screening and communicating changes to regulatory information to International Regulatory, Regulatory Intelligence and the local Affiliate
Monitor competitor regulatory information such as approvals, changes in label and other relevant local details.
Non Core (but critical) Technical Regulatory work
Support the Regulatory Head in pharmacovigilance, including :
Translating and processing of ICSRs (AEs and Special Situation Reports) from all sources
Follow-up of ICSRs as defined Gilead SOPs and taking other actions as required.
Search local literature sources for identification of ICSRs and other relevant PV information.
Key Differentiating Responsibilities / Contributions
Responsible for preparing regulatory submissions with direct supervision from more senior regulatory personnel which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations preparing or contributing to preparation of original clinical trial applications and contributing to preparation of marketing authorizations for assigned product(s).
Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license for assigned products and territories.
Participate in group meetings and present project status updates and strategic approaches to moderately complex programs / projects.
Responsible with manager for development and acquisition of required regulatory skills and knowledge.
May initiate or contribute to local process improvements, which have a significant impact on the working of the Regulatory Affairs function or other departments.
Work is performed under supervision of senior regulatory personnel.
Professional Experience / Key Skills
Typically requires a degree in a scientific field and relevant experience in regulatory affairs
Experience in and understanding of role of RA and regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local territory is preferred
Excellent organization skills and ability to work on a number of projects with tight timelines is required.
Excellent verbal and written communication skills and interpersonal skills are required
Good knowledge of regulatory systems is required
Very good verbal and written English is required
Meet the team :
https : / / regulatoryaffairs-careers.gilead.com /