Senior Pharmaceutical Affairs Manager

🕒 June 3

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BeOne Medicines

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10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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 • Reviews and approves promotional and non-promotional material • Maintains the local quality manual • Maintains and develops local GxP training oversight for DE/AT staff • Supports in product recalls/mock recalls • 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 • Oversees EU E2E labelling process • Coordinates local activities in relation to EU labelling change procedures and other regulatory life cycle management activities • 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)

🎯 Requirements

• 7+ years experience within the GxP/Regulatory field, preferably in affiliate settings • Fluent German & English

🏖️ Benefits

• Equal opportunity employer