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.
In the position of Associate Regulatory Program Director as an individual contribution in Pharma Technical Regulatory (PTR), you will be accountable for handling all Health Authority interactions pertaining to CMC Information (for example CMC information in an IND, IMPD and NDA/BLA/MAA filings), as well as informational and pre-submission meetings with global Health Authorities, partners and industry experts.
Your responsibilities may include a wide variety of contributions: partnering with key stakeholders, working on synthetic and biologic products with opportunities to work across the product lifecycle and combination products, collaborating with affiliates and partnering with the Policy team to influence HAs, or contributing to key initiatives that shape our technical, business and healthcare environments.
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 be accountable for driving and execution of end to end MOW filing strategy and incorporation of reliance pathways to ensure the right first time approach is adopted across all filing types including renewals.
You will be accountable for the compliance and accuracy of the data in regulatory documents , in regulatory information management systems and ensure success of technical regulatory team outcomes including the timely regulatory approval of Roche products.
You will ensure cross-functional PTR deliverables are completed compliant, accurate, and are high quality , delivered in a timely manner by identifying opportunities, mitigating risks and supporting continuous improvement.
You will understand the structure, key roles and responsibilities of local and international regulators; understand global health authority regulations and ICH guidelines and ensure faster access through optimal regulatory pathways, reliance and convergence
For CMC related Q&A from international markets you will provide strategic guidance with regards to country requirements and the available Policy tools (e.g. position papers) to the authors on the response as needed.
As a Country Responsible, provide expert knowledge on CMC regulatory requirements and local environment for International countries and update impacted global standards/systems to reflect current regulatory requirements.
Who you are
You will have a Bachelor’s Degree in life science disciplines, Post Graduate Degree is a plus with a minimum of 5 or more years of industry experience in technical regulatory CMC such as manufacturing or quality-related fields in the pharmaceutical/biotechnology industry.
You will have experience in developing global regulatory strategies and scenario planning with robust regulatory risk assessment.
You will have knowledge of relevant global Health Authority guidelines and experience in interacting with health authorities.
You will have a technical understanding of drug substance, product manufacturing, critical quality attributes, control system, process changes, and comparability in biologics is highly preferred.
Your 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 will be an added advantage
Preferred:
Experience with biologic products is desired
Relocation benefits 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.
