Associate Regulatory Program Director - 1 Year Contract

Roche Holding AG; Mississauga; On-site; CAD 115,000 - 151,000; Full time

Job summary

Roche Holding AG in Mississauga seeks an Associate Regulatory Program Director in Pharma Technical Regulatory (PTR) to lead Health Authority interactions for CMC information across IND/IMPD/NDA filings. You’ll partner with stakeholders across the product lifecycle and support cross-functional regulatory excellence.

In this role you will craft regulatory strategies, ensure data integrity in regulatory documents, and drive timely regulatory approvals while navigating global guidelines and health

Qualifications

• Bachelor's degree in life sciences required.
• Minimum 5 years' industry experience in technical regulatory CMC.
• Experience developing global regulatory strategies and risk assessment.

Responsibilities

• Submit high-quality CMC regulatory documents to health authorities globally in line with cGMP and Roche standards.
• Develop, communicate, and execute global regulatory strategies.
• Ensure data accuracy in regulatory documents and information management systems.
• Contribute to regulatory squad outcomes and timely product approvals.
• Understand regulatory bodies and ICH guidelines; support best-practice processes.
• Oversee timely responses to Health Authority inquiries during the product lifecycle.

Skills

Regulatory strategy

Global regulatory interactions

CMC regulatory knowledge

Education

Bachelor's degree in life sciences

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. 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 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.