Technical Regulatory Program Director
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Job Location:
Basel - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 Bachelors degree 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 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 life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Director
Key Skills
- Nurse Management
- Program Management
- Employee Evaluation
- Management Experience
- Teaching
- Curriculum Development
- Administrative Experience
- Budgeting
- Leadership Experience
- Program Development
- Supervising Experience
- Addiction Counseling
About Company
Petrochem is a market leader in chemical distribution and connecting chemical manufacturers and chemical users throughout the world. Petrochem provides business-to-business distribution solutions for industrial and specialty chemicals. With over10,000products and a highly diverse supp ... View more
