Group Leader in Technical Regulatory Small Molecule Development
Do you want to lead a team of regulatory professionals supporting several Small Molecule drugs and Oligonucleotides from Entry-into Humans up to global market approval. This includes setting performance objectives, providing timely feedback, and ensures alignment of short-term development goals with longer-term career goals? Do you want to lead cross-functional regulatory initiatives and strategies? As Group Leader in Technical Regulatory Small Molecule Development you will work with regulatory and cross-functional partners to continue to improve processes and drive for high standards in drug development.
Your responsibilities will include:
- Guide and oversee the implementation of regulatory strategy and making decisions that ensure the high quality of submissions in alignment with the global product management strategies
- Provide leadership for a team of about 5 regulatory professionals
- Drive the application and alignment of regulatory strategies and concepts across multiple disciplines and organizations
- Develop, execute and provide oversight over regulatory initiatives and strategies of significant complexity and apply creativity to solve problems and mitigate potential regulatory challenges
- Collaboration with management and technical regulatory leads in leading communications with on projects and initiatives of major complexity
- Serve as the voice of the organization and ensure that challenges, opportunities and initiatives / actions taken by the leadership teams are communicated to the employees in a meaningful, systematic and thoughtful manner
- Identify continuous improvement opportunities to drive regulatory consistency and efficiency and stay abreast of internal and external developments and trends to maintain a current perspective of implications for all programs
- Act as external spokesperson on behalf of Roche to influence regulatory topics proactively and intentionally
We are looking for someone with a Master's Degree in the area of Life Sciences, a Post Graduate Degree is a plus. In addition, you bring 6 or more years of work experience in the pharmaceutical, chemistry or similar with exposure to CMC, quality, regulatory or related areas. Experience as Tech Regulatory Leader (TRL) for a development/marketed product program or similar experience is a strong plus as you will need a thorough understanding of relevant global Health Authority guidelines and regulatory strategy development. In addition you have the following skills and qualifications:
- Technical understanding of drug substance and product manufacturing, as well as chemistry, solid phase synthesis and product development processes.
- Familiar with drug development, commercialization process, supply chain complexity and Pharmaceutical Quality Systems and knowledge of multidisciplinary functions involved in drug development, manufacturing, commercialization and product lifecycle management
- Experience as people leader or leading cross-functional teams whilst representing the Roche Leadership competencies is desired
- Excellent communication and presentation skills in English; ability to synthesize and summarize complex issues and conclusions so as to expedite agreements and decision-making
- Drive for continuous improvements and operate with a lean mindset
- Great interpersonal and collaboration skills; able to build strong and sustainable relationships with internal as well as with external partners and regulators. Excellent influencing and negotiation skills at all levels of the organization
- Excellent organizational and time management skills; proven ability to work under pressure
International travel will be required (approx. 20 %).
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
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- Wer wir sind At Roche, 94,000 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.
Roche is an equal opportunity employer.