Drug Regulatory Affairs Associate

Job description

·  Job facts

Primary Responsibilities :

• You will ensure timely request and submission to Health Authorities of all registrations items required for new products, new indications, line extensions , you will monitor the registration process in order to obtain regulatory approvals in due time.

• You will ensure timely submissions and approvals for upcoming products variations and products renewals.

• You will identify, request and follow up on required items for various regulatory activities.

• You will establish effective communication network with internal partners, interacting with various functions to support business, Business Development, Marketing, Pricing, Field Operations and Supply Chain.

• You will use and implement appropriate SOP's as required by Global Policies and local regulations.

• You will ensure the local label creation and packaging development will meet the local and corporate criteria's.

• You will validate of packaging material at the LNCPP.

• You will support responses and issue resolution with regulators.

• You will archive documents (i.e. documents related to the quality aspects of whole sale activities, regulatory documents and others) according to the local regulation and global requirements.

• You will submit and follow up promotional materials and ensure timely approvals.

• You will timely declare events

• You will prepare regulatory documentations for submission of tenders and importation programs.

Education/Qualifications:

• Pharmacy diploma (mandatory)

• High technical and organizational skills

• Strong communication skills

• Good knowledge of written and spoken English

·  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.