Associate Regulatory Program Director
4 weeks ago
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
The Position:
A 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.
As an Individual Contributor, 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 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.
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 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 PTR deliverables are completed compliantly, accurately, thoroughly and in a high quality and timely manner.
You will contribute to the success of technical regulatory team 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 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 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.
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 biologics is highly preferred.
In addition you will also have 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:
A Postgraduate Degree is a plus.
Experience with biologics products is added advantage
Relocation benefits are not available for this position
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 Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.
As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.
Roche is an Equal Opportunity Employer.
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