Associate Regulatory Group Director

Job description

The Position

People Leader (PL) in Submission and Information Management (SMG),  Pharma Technical Regulatory has a broad understanding of the regulatory landscape and applies their knowledge in the execution of deliverables aligned with our Vision. You are accountable for advocating and driving changes throughout the organization and supporting our people in an agile environment. With a thorough understanding of priorities and areas of high impact, you connect the right people and resources with the right work and help the organization adapt to evolving regulatory requirements. You will inspire all of our people to boldly innovate, collaborate and create outcomes that matter for patients, stakeholders and the company. 

Your Impact

As an SMG PL, you are providing effective leadership to a team of regulatory operations professionals located globally, which includes coaching, providing timely feedback, ensuring alignment of short-term development goals with long-term career aspirations and providing performance management of direct reports. 

You are enabling self-managed teams by being visionary, and an architect, coach and catalyst to the organization. Providing strategic input to self-managed teams with an emphasis on submission management and technical regulatory dossier preparation using established processes, systems, technology and tools. You have strong influencing skills and proven abilities to get things done without formal authority. Remarkable judgment and decision-making skills: past results are indicative of consistently sound business decisions. 

Who you are

• You have a Bachelor’s or higher degree (or equivalent) in biology, chemistry, English, or a similar field of study.

• Demonstrated success with people management, including experience coaching or training others in scientific editing.

• Thorough knowledge of eCTD and CTD filing requirements, as well as global filing requirements. 

• In-depth knowledge of document management best practices.   

• Scientific editing experience, thorough knowledge of in-house and standard style manuals (e.g., The Chicago Manual of Style), and an excellent grasp of scientific terminology is beneficial  

• Publishing experience in a regulatory environment is beneficial. 

Competencies

• You build genuine and trusting relationships inside and outside of Roche and can flourish in a diverse team

• You demonstrate effective problem-solving, excellent interpersonal skills and the ability to prioritize multiple tasks

• You have a proven ability to lead successful negotiations with internal and external stakeholders and consistently demonstrate efficient influential skills

• You understand processes, systems, and tools used to create, store, organize, maintain, and distribute regulatory data and content that are critical to PTR.

• You have an understanding of the digital evolution and related opportunities and challenges (eg. automation awareness). 

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.