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Roche

Direct Materials Regulatory Filings Expert

Mississauga, ON, Canada

Full-time

Apply About employer

Applications open in a new tab.

Job details

Job type: Full-time
Apply by: Nov 2, 2026
Experience: Experience & Education: BS/MS/PhD in Science, Engineering or Management with at least 5 years of experience in the pharmaceutical, pharmaceutical or medical device industry.
Posting language: English
Posted: Oct 3, 2026

Original job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

At Roche, we believe that every patient deserves access to life-changing innovations. As a global healthcare leader operating across pharmaceuticals and diagnostics, we combine cutting-edge science, advanced technology, and a passion for improving lives to address some of the world’s most challenging medical needs. Driven by our commitment to research and sustainable healthcare solutions, we foster an inclusive, collaborative environment where diverse teams are empowered to question the status quo, drive continuous improvement, and redefine what is possible in modern medicine.

The Pharma Technical (PT) Operations Global MSAT & Engineering group takes bold steps to modernize technical operations to enable Roche to deliver medicines for patients more quickly, efficiently and reliably. PTT shapes and accelerates technology innovation and product lifecycle management for tomorrow, while standardizing and driving operational excellence in PT today.

The PTT Direct Materials Certification and Filing Expert, reporting to the PTT Direct Materials Certification and Filing Team Lead, is responsible for providing technical oversight and proactively implementing solutions supporting Direct Materials and distribution networks. The position is accountable for the various filing requirements and appropriate certification of our products, including oversight of current Health Authority regulations regarding biological-derived materials. This role requires innovative, efficient, and sustainable technical solutions to ensure a robust and flexible supply chain and deliver processes that enable distribution of healthy products across the product life cycle.

The Oppurtunity

Accountable for the design and robust execution of the Certification and Filings business process and oversight of content for Biologics and Synthetic Molecules (e.g., BSE/TSE, GMO, virus-risk)
Accountable for proactive management of Direct Materials Filing Strategies in alignment with PTR to ensure compliance with relevant Health Authority requirements
Accountable for building collaborations and work relationships between key stakeholders and user groups including External Quality, Procurement, Planning, QC, QA, Manufacturing, Development, and Regulatory
Responsible for authoring, reviewing and/or approving Certificates and Filing sections with legalization signature responsibilities for Roche products
Maintains a state of global inspection readiness at all times and is responsible for implementing compendia changes and/or changes related to Health Authority audits
Responsible for owning and/or assessing information requests related to material topics to support Product Health
Lead Direct Material Management data improvement activities, driving successful implementation of programs including data management, systems understanding, and process design

Who you are:

Experience & Education: BS/MS/PhD in Science, Engineering or Management with at least 5 years of experience in the pharmaceutical, pharmaceutical or medical device industry. Experience in regulatory filings and/or material specifications is an advantage

E2E Thinking: Experience working in/leading teams in a global setting

Technical Expertise: Must possess advanced project management skills with working knowledge of ICH guidelines, ISO standards, Pharma GMP operations, and Health Authorities regulations. Knowledge of Quality Systems (CAPA, Change Management) and Operational Excellence tools (Six Sigma, Lean) is desired

Strategic E2E Thinker: Ability to align with matrix leadership model, combining strategic clarity with innovative and coaching capabilities

Outstanding Communicator and Influencer: Ability to build connections, encourage feedback, and foster a collaborative environment with an understanding of business needs

Inclusive and Open Minded: Committed to creating an inclusive environment where team members feel safe, valued, and empowered to perform their best

Travel: <10% of travel required

Relocation is not offered for this position**

The expected salary range for this position based on the primary location of Mississauga is 115,328.00 and 151,368.00 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.

We use artificial intelligence to screen, assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

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More about this job

Responsibilities

Oversee direct materials certification and filing strategies, including regulatory content for biologics and synthetic molecules, and author, review, or approve certificates and filing sections. Maintain inspection readiness, implement regulatory and compendial changes, respond to material information requests, and lead data and process improvement initiatives across global stakeholder groups.

Requirements

Requires a BS, MS, or PhD in science, engineering, or management and at least five years of experience in the pharmaceutical or medical device industry; regulatory filings or material specifications experience is an advantage. Candidates should have global team experience, advanced project management skills, working knowledge of ICH guidelines, ISO standards, GMP operations, and health authority regulations, with quality systems and operational excellence knowledge desired.

Skills

Regulatory Filings
Direct Materials Management
Material Specifications
Project Management
ICH Guidelines
ISO Standards
Pharmaceutical GMP
Health Authority Regulations
Quality Systems
CAPA
Change Management
Six Sigma
Lean
Regulatory Compliance
Stakeholder Collaboration
Data Management

Visa sponsorship

Not detected in the job text

Keywords

Direct Materials
Certification
Regulatory Filings
Biologics
Synthetic Molecules
BSE/TSE
GMO
Virus Risk
Health Authority Regulations
ICH Guidelines
ISO Standards
Pharmaceutical GMP
Material Specifications
Filing Strategies
Certificates
Legalization Signatures
Inspection Readiness
Compendia Changes
Health Authority Audits
Product Health
CAPA
Change Management
Six Sigma
Lean
Project Management
Data Management
Process Design
Supply Chain
Operational Excellence

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