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 PositionA healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
At Roche, we believe in empowering you to thrive and do your best work. By bringing together our unique strengths in technical regulatory affairs, medicines, and technology, you will collaborate in an environment that nurtures growth, values your unique perspective, and drives sustainable innovation to transform healthcare for patients worldwide.
In the position of Associate Regulatory Program Director in Pharma Technical Regulatory (PTR), you will be accountable for handling all Health Authority interactions pertaining to CMC Information (for example in an IND, IMPD and NDA/BLA/MAA filings), as well as informational and/or pre-submission meetings with global Health Authorities, partners and industry experts. This role requires leadership in partnering with key stakeholders, working on both synthetic and biologic products with opportunities to work across the product lifecycle, collaborating with affiliates, and partnering with the Policy team to influence Health Authorities.
The Opportunity:
- You will be responsible for submission of high-quality CMC regulatory documents to health authorities globally according to current Good Manufacturing Practices (cGMP), Roche corporate standards, and the requirements of applicable health authorities and other regulatory agencies.
- You will develop, communicate and execute robust regulatory strategies that align with global regulatory requirements.
- You will also be accountable for the compliance and accuracy of the data in regulatory documents and in regulatory information management systems. In addition, you will ensure cross-functional deliverables are completed compliantly, accurately, thoroughly and in a high quality and timely manner.
- You will contribute to the success of technical regulatory squad outcomes and to the timely regulatory approval of Roche products and contribute to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
- You will be required to understand the structure, key roles and responsibilities of local and international regulators, global health authority regulations and ICH guidelines as well as support departmental business processes to document and improve best practices and work efficiency.
- You will oversee timely responses to Health Authority questions received from major/global regulators while ensuring excellence in regulatory compliance throughout the product lifecycle and support cross-functional compliance processes to maintain right to operate.
Who you are:
- You will have a Bachelor’s Degree in life science disciplines
- A minimum of 5 years of industry experience in technical regulatory CMC.
- You will have experience in developing global regulatory strategies and scenario planning with robust regulatory risk assessment.
- Your strengths lie in knowledge of relevant global Health Authority guidelines and experience in interacting with health authorities.
- You will have technical understanding of drug substance, product manufacturing, critical quality attributes, control system, process changes, and comparability.
- In addition, you will also have general knowledge of drug development, commercialization process, supply chain complexity and Pharmaceutical Quality Systems and knowledge of multidisciplinary functions involved in drug development (all functions), manufacturing, commercialization and product lifecycle management.
Preferred:
- Biologics, Device or Peptide experience would be considered a strong asset.
- A Postgraduate Degree is a plus.
Relocation benefits are not available 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 areA 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.
Skills Required
- Bachelor's degree in a life science discipline
- Minimum 5 years of industry experience in technical regulatory CMC
- Experience developing global regulatory strategies and scenario planning with regulatory risk assessment
- Knowledge of global Health Authority guidelines and experience interacting with Health Authorities
- Technical understanding of drug substance, product manufacturing, critical quality attributes, control systems, process changes, and comparability
- General knowledge of drug development, commercialization, supply chain complexity, Pharmaceutical Quality Systems, and multidisciplinary product lifecycle functions
- Biologics, device, or peptide experience
- Postgraduate degree
Roche Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.
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Retirement Support — U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
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Leave & Time Off Breadth — Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
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Healthcare Strength — Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.
Roche Insights
What We Do
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).
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