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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