Regulatory Affairs Analyst

Job description

·  Job facts

Participate in the process of preparing the documents required for the approval of the various procedures to the local health authorities, in accordance with current local legislation and company policy.

Strategy/Planning:

·  Gather, analyse and communicate internal and external regulatory intelligence
·  Provide regulatory expertise and input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
·  Develop innovative, risk-based registration plans and submissions strategies for Affiliate products with limited guidance from DRA Management
·  Represent Affiliate Regulatory in cross-functional teams

Filings:

·  Adapt global product dossiers to local requirements
·  Prepare and manage regulatory registration filings across product lifecycles
·  Monitor and communicate all regulatory filings status and respond to internal and external questions, or other needs
·  Ensure timely regulatory filings submissions and approvals
·  Influence internal and external stakeholders for successful regulatory outcomes

Information and Documentation Management:

·  Manage Affiliate regulatory activities on relevant Roche systems

Regulatory Compliance:

·  Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards
·  Ensure regulatory inspection-readiness for the Affiliate, as per assigned responsibilities
·  Ensure regulatory compliance for product released to market according to marketing authorizations

Other:

·  Manage end-to-end local product packaging and labelling from a regulatory perspective
·  Where applicable, review and approve promotional materials to provide regulatory input and guidance across the Affiliate
·  Where applicable, provide regulatory administrative support for local lot releases
·  Support local market access activities from a regulatory perspective

Local detailed description:

·  Collaborate with the design and update of the shared databases of the area in order to facilitate the easy tracking of the different files, according to the needs and diversity of the procedures.
·  Evaluation, preparation of documents related to the risk management plans agreed with the RMP Coordinator and his/her deputy.
·  Collaborate in the preparation and training of procedures of the Regulatory Affairs Area.
·  Manage Vademecum tool to document requirements of the health authorities.

Experience:

·  3 to 4 years in specific technical areas (QA, QC, Regulatory Affairs, Clinical Studies)

Knowledge:

·  University graduate (Pharmaceutical and/or related careers) and/or advanced student of these careers.

Skills:

·  English. Advanced level.
·  Informatic tools: Office, Data bases

Others:

·  Administrative knowledge, regulatory procedures and local legislation

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.