Job Description

The Position

The Regulatory Affairs Specialist is responsible for submitting regulatory applications and performing associated activities, to ensure the rapid and optimal registration for new Roche Pharma products, indications, and life cycle management and all regulatory related activities. The role supports ongoing regulatory compliance and maintains existing registrations throughout a product's lifecycle. The Regulatory Affairs Specialist works with agents, communicates with health authorities to achieve timely approval and the broadest use of products for Roche.

Your Responsibilities

Effectively and timely support regulatory for product management by ensuring all regulatory applications and activities occur within defined timelines according to regulatory guidelines and business requirements

Develop innovative strategies and plans for affiliate products with guidance from DRA Management

Interacting with local authorities for DRA submission with guidance from DRA Management

Supports regulatory activities according to the regulatory strategy to achieve the best business outcomes for Roche Gulf Countries

Follow Roche processes and procedures and local requirements regarding the registration of New Drug Application, line extensions, new indications, safety updates, variations, renewals, site registration and any other related changes and other regulatory activities with Health Authorities

Assess product dossier information received. Adapt global product dossiers to local requirements. Collate, manage and prepare all regulatory submissions. Submit the dossier in timely manner

Review activities on a regular basis with RAM and any other internal business partners and stakeholders

Circulate regulatory submissions for internal approvals according to legislative and regulatory requirements, local, regional and global Standard Operating Procedures (SOPs)

Ensure agents to submit final, reviewed regulatory submissions to health authorities

Who You Are

You hold a Bachelor degree in Pharmacy. Additional business degree would be an advantage

You have built 2 - 3 years of experience regulatory affairs in Pharmaceutical industry and/or medical devices. Being familiar with code of conduct and Pharma regulations is preferred

You bring past experience working with health authorities and relevant (regulatory) governmental departments. Good Relationships with external TAEs, other thought leaders, and external organizations is strongly preferred

You are well organized, are able to prioritize, able to (project) manage your time, and have attention-to-detail

You are able to build and cultivate relationships with key partners/stakeholders, and are able to influence without authority

You built advance communication, interpersonal, and presentation skills both verbal and writing

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.