Overview
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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
Are you eager to join a team dedicated to bringing new medicines to patients? We are seeking a Technical Regulatory Program Director to join our Pharma Technical Regulatory (PTR) department.
This position plays a crucial role in developing new medicines and making them accessible worldwide. We provide strategy, expertise, and mentorship to offer top-tier technical regulatory support for the chemistry, manufacturing, and controls (CMC) components of clinical trial licensure applications, new market applications, and post-approval changes. We collaborate with health authorities and industry groups globally and are integral to our internal development and marketed product teams.
The Opportunity:
You support different types of modalities (small molecules, oligonucleotides, peptides) and product life-cycles with a focus on peptides. Furthermore you:
* Develop, communicate and implement robust regulatory strategies that align with global regulatory requirements
* Identify and communicate regulatory risks; develop and implement risk mitigation strategies in collaboration with technical functions
* Are responsible for authoring, reviewing and/ or submission of high-quality CMC regulatory documents to health authorities
* Represent PTR on cross-functional teams, such as Technical Development Teams (TDTs), Technical Product Teams (TPTs) and Regulatory Affairs Functional Teams (RAFTs) and work with diverse partners and personalities
Who you are
You have a Bachelor a0degree in a scientific field, preferably; advanced degree highly desirable. Furthermore:
* Confirmed experience in CMC regulatory submissions and strategy in different lifecycle stages, ideally including oligonucleotides and/ or peptides
* Effective matrix leadership skills, an agile strategic approach, and strong communication abilities
* Ability to lead, handle and communicate sophisticated CMC issues efficiently
* Demonstrated experience in successfully guiding complex global regulatory strategies and effectively managing high-stakes regulatory interactions with health authorities
* Comfortable taking measured risks, experimenting with new insights, and navigating ambiguity
Join us in our mission to improve global health - apply your expertise and passion to make a real difference. We offer a collaborative and inclusive environment where you can thrive and grow.
Who we are
A healthier future drives us to innovate. Together, more than 100 a0000 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 a0 0s build a healthier future, together.
Roche is an Equal Opportunity Employer. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual\'s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Seniority level
* Associate
Employment type
* Full-time
Job function
* Quality Assurance and Consulting
Industries
* Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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