Regulatory Data & Content Specialist - Clinical Trial Strategy and Submissions

Roche; Mississauga; On-site; CAD 70,000 - 90,000; Full time

Job summary

A global healthcare company in Mississauga is seeking a Regulatory Clinical Trial Expert to enhance patient access to treatments by providing strategic regulatory insights. Candidates should have 1-3 years of experience in clinical trials, strong communication skills, and a foundational understanding of EU regulations and GCP principles. This is an opportunity to make a significant impact in a dynamic environment that values personal and professional growth.

Qualifications

• 1-3 years of experience with local health authority.
• Foundational knowledge of EU clinical trial regulations.
• Familiarity with GCP principles.

Responsibilities

• Provide strategic guidance for regulatory clinical trial expertise.
• Lead global regulatory procedures for clinical study submissions.
• Monitor regulatory changes and ensure compliance.

Skills

collaboration skills

strong communication skills

regulatory knowledge

adaptability

Education

Bachelor's degree

Tools

EU Clinical Trial Information System (CTIS)

Veeva

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

The Opportunity:

• Opportunity to make an impact in a dynamic and multifaceted environment by leveraging global clinical trial regulatory expertise to accelerate patient access to treatments.
• Act as the first point of contact for regulatory clinical trial expertise, providing strategic guidance and insights to the organization.
• Serve as a strategic partner by challenging strategies, connecting ideas, and taking smart risks to drive innovative and forward-thinking solutions.
• Focus on accelerating global clinical studies to support the registration and launch of new products.
• Improve efficiencies by applying cross-study learnings and offering actionable insights into global clinical trial regulations.
• Proactively monitor and interpret regulatory changes to ensure compliance and align internal processes with evolving guidelines.
• Lead global regulatory procedures for clinical study submissions, engage with health authorities to secure approvals, and help shape the external regulatory environment.
• Emphasize personal and team growth through continuous learning, coaching, mentoring, and contributing to cross-organizational initiatives for process optimization.

Who you are

• 1-3 years of experience and a bachelor's degree, with local experience working with at least one health authority.
• Foundational knowledge of EU clinical trial regulations, IVDR, MDR, or other relevant clinical trial and device regulatory requirements outside Europe.
• Familiarity with GCP principles and exposure to tools such as the EU Clinical Trial Information System (CTIS) and Veeva, enabling effective support of clinical studies.
• Keen interest in developing regulatory skills through knowledge and hands-on experience.
• Growth-oriented, with the ability to assess priorities, adapt to dynamic environments, and contribute to evolving business and regulatory strategies
• Strong communication and collaboration skills, confident working with stakeholders like health authorities and external partners to achieve shared goals

Relocation benefits are not available for this position

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.