Associate Regulatory Program Director

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.

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. 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 the authoring, reviewing and/or 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.

• You will develop, communicate and execute robust regulatory strategies that align with global regulatory requirements. 

• You will be accountable for the compliance and accuracy of data in regulatory documents and information management systems. You will also ensure cross-functional PTR deliverables are completed in a compliant, accurate, high-quality, and timely manner.

• You will actively contribute to the success of technical regulatory team outcomes, the timely regulatory approval of Roche products, and drive for faster access through optimal regulatory pathways.

• You will contribute to regulatory excellence by identifying opportunities, mitigating risks, and supporting continuous improvement.

• You will be required to understand global health authority regulations and ICH guidelines and support departmental business processes to improve best practices and work efficiency.

• You will oversee timely responses to Health Authority questions received from global regulators while ensuring regulatory compliance throughout the product lifecycle to maintain the right to operate.

Who you are:

• You have a Bachelor's Degree in a life science discipline with a minimum of 8 years of industry experience in technical regulatory CMC, manufacturing, or quality-related fields in the pharmaceutical/biotechnology industry. 

• You have led the development of global regulatory strategies and scenario planning with robust regulatory risk assessment.

• Your strengths lie in your knowledge of relevant global Health Authority guidelines and experience interacting with them.

• You have a strong technical understanding of drug substance/product manufacturing, critical quality attributes, and process changes, particularly for biologics.

• You have knowledge of the drug development and commercialization process, supply chain complexity, and the multidisciplinary functions involved in product lifecycle management.

• You have the ability to work with an agile mindset and to drive for continuous improvement.

• You possess excellent communication, presentation, and collaboration skills, with a proven ability to build trusted relationships and synthesize complex information to support decision-making.

Preferred:

• Experience with biologics, devices, or peptides/oligonucleotides is considered a strong asset. 

Relocation benefits are not available for this position.

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.