Associate Regulatory Program Director - 1 Year ContractCandidatar-se: Data de término: 202610-125537At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, 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. # 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. # 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.

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. # **Biologics, Device or Peptide experience would be considered a strong asset.
- A Postgraduate Degree is a plus. Relocation perks are not available for this position. We use artificial intelligence to screen, assess or select applicants for this role.

📌 Associate Regulatory Program Director - 1 Year Contract (Mississauga)
🏢 F. Hoffmann-La Roche
📍 Mississauga