BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
• Local Pharmaceutical Affairs (Regulatory Affairs (Pre-Launch, Launch and Life Cycle Management) and Quality Assurance) Operations DE
• Deputy Information Officer
• Deputy GDP Responsible Person
Essential Functions of the job
:
Acts as local contact person or deputy local contact person for competent authorities in DE
Acts as deputy Information Officer
Acts as deputy GDP Responsible Person according section 52a German drug law
Supports in local internal and external audits as well as regulatory inspections incl. CAPA. Creates and reviews GxP relevant local governance documents within the RA and QA area, supports other functions (e.g. PV, Medical) in relation to creation and review of GxP relevant governance documents
Reviews and approves promotional and non-promotional material
Maintains the local quality manual
Maintains and develops local GxP training oversight for DE/AT staff and develops specific GxP trainings e.g. for sales representatives
Supports in product recalls/mock recalls
Processes product complaints
Owns and processes change controls
Owns and processes deviations
Coordinates local distribution activities at the interface to EU distribution and local distributors. Contributes to EU regulatory activities and enquiries such as HA requests, RA intelligence, etc in relation to Regulatory Life Cycle Management of marketed products as well as in relation to development products
Oversees EU E2E labelling process
Coordinates local activities in relation to EU labelling change procedures and other regulatory life cycle management activities, provides labelling source documentation and acts of owner of local label is owner of the LCM tracking database
Performs local commercial artwork proofreading and provides commercial artwork request and approval
Manages publication of SmPC (Fachinfo Service) and other publications ( e.g. Rote Liste)
Supports BeOne functions and departments (Market Access, Customer Engagement, Medical) in relation to GxP relevant enquiries and document requests and selected projects
Acts as BeOne representative in professional societies
Computer Skills
: M/S Office, Veeva Vault, SAP
Other Qualifications
: 7+ years experience within the GxP/Regulatory field, preferably in affiliate settings, Fluent German & English
Travel
: approx. 10%
Salary Range Germany: 103,200.00 EUR - 129,000.00 EUR
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.