Technical Regulatory Affairs (Regulatory CMC), Cell and Gene Therapies (CGT) page is loaded
Technical Regulatory Affairs (Regulatory CMC), Cell and Gene Therapies (CGT)
Apply locations Basel Penzberg time type Full time posted on Posted Yesterday job requisition id 202505-112843
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
At Roche, we are passionate about transforming patients’ lives and we are brave in both decision and action.
Are you passionate about transforming patients' lives and brave in both decision and action? Join Roche, a global leader in healthcare, and become part of our innovative journey in Cell and Gene Therapies!
At Roche, our Pharma Global Technical Operations (PT) division is at the heart of every product, from Phase I development to market maturity, with over 10,000 employees worldwide. As a key member of the Pharma Technical Regulatory Team for Cell and Gene Therapies (PTCR), you will contribute to a dedicated cross-functional team shaping the future of medicine.
As a PTCR team member, you will elaborate and execute regulatory strategies to drive the development of Cell and Gene Therapies, working closely with manufacturing sites to ensure regulatory compliance. You will also represent technical regulatory expertise both internally and with external partners.
The Opportunity
* Develop and execute comprehensive regulatory strategies for innovative cell and gene therapies, ensuring alignment with global regulatory requirements and facilitating timely approvals.
* Meticulously prepare and compile Chemistry, Manufacturing, and Controls (CMC) documentation for submission to health authorities worldwide, adhering to rigorous standards and guidelines.
* Lead and facilitate project teams and Health Authority meetings, fostering effective communication, collaboration, and decision-making to drive progress and achieve project milestones.
* Conduct thorough risk assessments to identify potential regulatory hurdles and proactively develop mitigation plans, minimizing delays and ensuring compliance.
* Actively collaborate with cross-functional teams on compliance matters, ensuring adherence to best practices, staying abreast of evolving regulations, and supporting influencing global policies.
* Efficiently manage change control processes, documenting and assessing the impact of changes on regulatory submissions and ensuring compliance throughout the product lifecycle.
Who you are
You are a highly motivated individual with a postgraduate degree (Master’s or PhD or equivalent) in Life Science and at least 5 years of experience in the biopharmaceutical industry, preferably in CMC, Regulatory, or R&D in Cell and Gene Therapies. You have a proven track record in global product development and are familiar with new and emerging gene editing technologies. Additionally, you have experience leading strategic regulatory activities from early development stages through market launch.
Your qualifications and competencies include:
* Business acumen: Knowledge of the Cell and Gene Therapies field, including the regulatory landscape,development, commercialization, and associated quality systems. You are strategically agile, proficient in business, project, and risk management principles, and adept at navigating novel areas with evolving regulatory expectations. You drive continuous improvement and are flexible in your approach.
* Collaboration and leadership: Demonstrated ability to work effectively in cross-functional teams, keeping stakeholders informed as needed. You take a pragmatic approach and think creatively.
* Prioritization and decision-making: Ability to effectively prioritize workload and make sound decisions, independently identifying critical tasks, developing, planning, and adjusting strategies. You exercise sound judgment, considering risks and benefits for successful outcomes.
* Influencing and negotiation skills: Drive optimal results through skillful collaboration with cross-functional team members without formal authority, adept at identifying solutions that meet all parties' needs.
* Communication: Excellent verbal and written communication skills, fluent in English.
Ready to make a difference? Apply now and join our team!
Who we are
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.
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We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.
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