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- Aufgaben: Lead regulatory strategies for innovative medicines, focusing on peptides and CMC submissions.
- Arbeitgeber: Join Roche, a global leader in healthcare innovation with over 100,000 employees worldwide.
- Mitarbeitervorteile: Enjoy flexible work options, extensive training, and generous parental leave policies.
- Warum dieser Job: Make a real impact on global health while thriving in a diverse and inclusive environment.
- Gewünschte Qualifikationen: Bachelor's in a scientific field; advanced degree preferred; experience in CMC regulatory submissions required.
- Andere Informationen: Collaborate with diverse teams and navigate complex regulatory landscapes.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
And as the world evolves, so do we. For over 125 years, we have tackled some of the most sophisticated challenges in healthcare.
Are you eager to join a team dedicated to bringing new medicines to patients? Roche is seeking a (Senior) Technical Regulatory Program Director to join our Pharma Technical Regulatory (PTR) department.
At Roche, Technical Regulatory 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:
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You support different types of modalities (small molecules, oligonucleotides, peptides) and product life-cycles with a focus on peptides.
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Develop, communicate and implement robust regulatory strategies that align with global regulatory requirements.
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Identify and communicate regulatory risks; develop and implement risk mitigation strategies in collaboration with technical functions.
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You are responsible for authoring, reviewing and/or submission of high-quality CMC regulatory documents to health authorities.
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You 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:
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Bachelor’s degree in a scientific field, preferably; advanced degree highly desirable.
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Confirmed experience in CMC regulatory submissions and strategy in different lifecycle stages, ideally including peptides.
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Effective matrix leadership skills, an agile strategic approach, and strong communication abilities.
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Ability to lead, handle and communicate sophisticated CMC issues efficiently.
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Demonstrated experience in successfully guiding complex global regulatory strategies and effectively managing high-stakes regulatory interactions with health authorities.
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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
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche’s largest sites. Read more .
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
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(Senior) Technical Regulatory Program Director New Modalities Arbeitgeber: F. Hoffmann-La Roche Gruppe
Kontaktperson:
F. Hoffmann-La Roche Gruppe HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: (Senior) Technical Regulatory Program Director New Modalities
✨Tip Number 1
Familiarize yourself with the latest trends and regulations in CMC submissions, especially regarding peptides. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs community, particularly those who have experience with Roche or similar companies. Engaging in discussions can provide insights into the company culture and expectations, which can be invaluable during the application process.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully navigated complex regulatory challenges in the past. Highlighting your problem-solving skills and ability to manage high-stakes interactions will resonate well with the hiring team.
✨Tip Number 4
Showcase your leadership abilities by discussing experiences where you've led cross-functional teams or projects. Roche values effective matrix leadership, so demonstrating your capacity to collaborate with diverse partners will strengthen your candidacy.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: (Senior) Technical Regulatory Program Director New Modalities
Tipps für deine Bewerbung 🫡
Understand the Role: Take the time to thoroughly read the job description for the (Senior) Technical Regulatory Program Director position. Understand the key responsibilities and required qualifications, especially focusing on CMC regulatory submissions and strategies.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience with CMC regulatory submissions, particularly in relation to peptides and other modalities. Use specific examples to demonstrate your leadership skills and ability to manage complex regulatory interactions.
Showcase Communication Skills: Since strong communication abilities are crucial for this role, make sure to highlight instances where you effectively communicated complex regulatory issues or collaborated with cross-functional teams. This can be a key differentiator in your application.
Tailor Your Application: Customize your cover letter to reflect Roche's values of diversity, equity, and inclusion. Mention how your unique background and experiences align with their mission to improve global health and how you can contribute to their collaborative environment.
Wie du dich auf ein Vorstellungsgespräch bei F. Hoffmann-La Roche Gruppe vorbereitest
✨Showcase Your Regulatory Expertise
Be prepared to discuss your experience with CMC regulatory submissions and strategies, especially in relation to peptides. Highlight specific examples where you successfully navigated complex regulatory challenges.
✨Demonstrate Leadership Skills
Roche values effective matrix leadership. Share instances where you've led cross-functional teams or collaborated with diverse partners, emphasizing your ability to communicate and manage sophisticated issues.
✨Communicate Your Strategic Approach
Articulate how you develop and implement regulatory strategies that align with global requirements. Discuss any risk mitigation strategies you've employed and how they contributed to successful outcomes.
✨Embrace Diversity and Inclusion
Roche fosters a culture of diversity and inclusion. Be ready to express your understanding of its importance in healthcare and how you can contribute to creating an inclusive environment within the team.
