Senior Pharmaceutical Affairs Manager Germany

BeiGene, Ltd.; Deutschland; On-site; USD 119,777 - 149,721; Full time

Job summary

BeiGene, Ltd. is looking for a Senior Pharmaceutical Affairs Manager based in Germany. The successful candidate will oversee local Pharmaceutical Affairs operations, manage GxP compliance, and support regulatory inspections. This role requires strong leadership skills and a deep understanding of the regulatory environment.

Ideal applicants will have over 7 years of relevant experience, be fluent in both German and English, and possess expertise in regulatory affairs and quality assurance processes.

The job offers a salary range of 103,200.00 EUR to 129,000.00 EUR, with an expected travel of approx. 10%.

Qualifications

• 7+ years experience within the GxP/Regulatory field, preferably in affiliate settings.
• Acts as local contact person or deputy contact for authorities in DE.
• Supports inspections and creates GxP documents.

Responsibilities

• Acts as deputy Information Officer and GDP Responsible Person.
• Coordinates local distribution activities and contributes to regulatory activities.
• Processes product complaints and owns change controls.

Skills

GxP knowledge

Fluent German

Fluent English

Regulatory Affairs experience

Quality Assurance knowledge

Tools

M/S Office

Veeva Vault

SAP

Job description

## Senior Pharmaceutical Affairs Manager GermanyApplylocations: Germany Remotetime type: Full timeposted on: Posted Todayjob requisition id: R34926BeOne 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 EURGlobal CompetenciesWhen 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 ClarityWe 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.