Biotechnologist - Office Head Global CMC, Regulatory Affairs (m/f/d)

Beschreibung

Office Head Global CMC RA

Germany / (All Regions) / All Locations
Germany / (Baden-Württemberg) / Biberach
Germany / (Rhineland-Palatinate) / Ingelheim

JOB ID: 2114152
JOB LEVEL: Experienced
FUNCTIONAL AREA: Regulatory / Compliance
SCHEDULE: Full-Time

OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.Tasks & responsibilitiesLead an Office of CMC RA-Managers responsible for biological & ATMP development projects and approved biological products:

• In your role as office head, you have global responsibility for CMC regulatory topics pertaining to development and approved products within the office.
• You supervise, train and guide the CMC RA managers and actively support their functional as well as personal development in accordance to Talent Management principles.
• Furthermore, you define goals within the office and monitor the implementation of these.
• You are responsible for capacity steering and product/project assignments. In addition, you conduct the annual performance review with your direct reports.
• With your expertise, you contribute to development, innovation and continuous improvement of processes and standards within Regulatory Affairs.
• You represent Global CMC Regulatory Affairs on general, inter-disciplinary strategic projects and represent BI on external industry groups. Moreover, you maintain up-to-date knowledge and expertise within the global CMC regulatory environment (ICH, FDA, EMA, PMDA and Emerging Markets).
• In addition to your responsibilities as office lead, you also manage global CMC regulatory tasks during development and product life cycle.

Global management of CMC regulatory tasks and responsibilities in development as well as during product life cycle:

• In this function, you represent the department in international project teams and provide regulatory advice regarding global CMC regulatory requirements, CMC submission strategies and opportunities for seeking scientific advice from health authorities.
• It is your responsibility to guide project teams to prepare high quality global registrations documents and responses to health authority requests and ensure that timelines will be met.
• In addition, you plan, define, review and compile global Module 3 documentation for Clinical Trial Applications, Marketing Authorization Applications as well as for post approval CMC activities (e.g. CMC changes and renewals).
• Furthermore, you will review CMC documentation for in-licensing products.

Requirements

• Master’s degree in Biotechnology, Biochemistry, Pharmacy, Chemistry, or Biology
• First experience in team management
• In depth global CMC regulatory experience for biologicals and/or ATMPs as well as for drug-device combination products
• Experience in CMC development and/ or production/control of biologicals and /or ATMPs with sound scientific understanding of products and processes
• Ability to lead and motivate people, set directions and manage changes
• Inter-disciplinary, innovative and strategic thinking
• Strong communication skills
• Strong organizational skills, excellent prioritization and time management skills
• Risk identification and problem-solving skills
• Fluent in English (written and spoken); German language would be a plus

EFFECTS OF COVID-19

We will continue to hire talented people and we look forward to receiving your applications. As a result of COVID-19, we have introduced alternative working arrangements to ensure that our employees can stay safe and healthy, because the health of our employees is among our top priorities. At all company locations, we work remotely whenever possible. Additionally, we are now hosting virtual video interviews for applicants. During the limited in-person interviews we still have during this time, we pay special attention to distance and the hygiene rules recommended by the Robert Koch Institute. New employees who do not start on site in production or the laboratories are sent the necessary IT equipment, our Welcome Days take place online, and we plan to conduct their onboarding training virtually whenever possible.WHY BOEHRINGER INGELHEIM?This is where you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area.

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.