Senior Pharmaceutical Affairs Manager Germany

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.