Associate Regulatory Program Director
Associate Regulatory Program Director
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Salary Not Disclosed
1 Vacancy
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
A healthier future. Its 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.
Thats 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 presubmission meetings with global Health Authorities partners and industry experts.
The Opportunity:
You will be responsible for submission of highquality 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 crossfunctional 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 crossfunctional compliance processes to maintain right to operate.
Who you are
You will have a Bachelors Degree in life science disciplines with a minimum of 5 or more years of industry experience in technical regulatory CMC such as manufacturing or qualityrelated 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:
Biologics Device or Peptide experience would be considered a strong asset
A Postgraduate Degree is a plus.
Experience with biologics products is added advantage
Relocation benefits are not available for this position
Who we are
A healthier future drives us to innovate. Together more than 100000 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 lifechanging healthcare solutions that make a global impact.
Lets build a healthier future together.
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 Roches truly innovative culture.
Roche is an Equal Opportunity Employer.
Required Experience:
Director
Employment Type
Full-Time
