Job Description

The Position

The Roche Oman early in career Program is a 6 months rotational development program at Roche. The program is tailored for high potential individuals at an early stage of their career, and NO work experience is required. The program accelerates their professional development and enables them to be key contributors to Roche's purpose and what patients need next. Roche Oman offers a Quality specialist & Regulatory Associate/ position for a period of 5 months and a one-month rotation with the below main responsibilities:

Filings

Adapt global product dossiers to local requirements

Prepare and manage regulatory registration filings across product life cycles

Monitor and communicate all regulatory filings status and respond to internal and external questions, or other needs

Ensure timely regulatory filings submissions and approvals

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 products released to market according to marketing authorizations

Other

Support local market access activities from a regulatory perspective

Quality Specialist

Owns the locally controlled document management process and implements and maintains a local process (where needed) that describes the creation and management of local procedural documents in line with global and local regulatory requirements.

Ensures the consistent alignment between local and global procedural documents with local regulatory requirements and ensures effective implementation.

Ensures that the local GCP/GVP Controlled Documents are uploaded and maintained in the Document Management System

Oversees the GCP/GVP service provider management process by liaising with key stakeholders to ensure that oversight plans are in place, the performance of the vendor is regularly monitored and accurate, and regular risk assessments are completed & documented, and actions are taken where required.

Drives and enables the overall CAPA Management process at the local level.

Implement the global PD training process for QMS activities, and ensure that an aligned local training strategy is in place.

Proactively monitor and oversee external regulatory changes affecting affiliate QMS in alliance with process owners and ensure that the local regulatory requirements are implemented.

Pharmacovigilance

Oversight on the Roche Pharmacovigilance system and ensures relevant procedures and processes within the PV system and documented, monitored and improved.

Ensures timely submission of PV related documents in accordance with regulatory requirements.

Oversight of the risk/benefit profile of Roche medicinal products including risk management activities and emerging safety concerns.

Ensures a complete and timely response to safety-related requests from competent authorities.

Contributes to the efficient, high-quality operational execution of Safety-related activities relevant to the PV system in partnership with the Pharmacovigilance Hub(s) to ensure monitoring of the safety profile of Roche products.

Collaborates with internal and external interfaces and acts as a PV contact person as needed

Your Opportunity

Participants build an extensive network within Roche and upskill themselves

Best possible work environment is designed to foster participants' learning experience

Participants will have access to senior leaders and will be assigned to a mentor to support their career journey

Contributing to purpose driven projects and taking responsibilities from day 1

Who You Are You hold a Bachelor's or Master's Degree in Life Sciences, Economy, Business, Public Affairs or any related area You are at an early stage in your career. Fresh graduates will be preferred Preferably, you have a basic understanding of the healthcare system You are eager to work with diverse cultures You are curious and have passion for learning new things, and have high degree of integrity and courage You have excellent communication and innovative skills You are proficient in English

Our mission Roche is a global pioneer and leader in Personalized Healthcare. We provide breakthrough differentiated medicines and diagnostic tests using expertise in Science, Technology, and Data so that people can live better lives. We believe it is urgent to deliver medical solutions right now - even as we develop innovations for the future. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We are living in truly historic times. The rapid digitalization of healthcare fuels an accelerated transformation in our industry. This change requires leaders who are entrepreneurial, who trust & encourage teams to take risks, learn and progress quickly.

Program Characteristics/Scope

A rotational talent development program

6 months in different disciplines

Who we are

At Roche, more than 100,000 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.