Senior Manager Compliance and Certification coordinating external audits and compliance at D - Trust GmbH in Berlin. Ensuring regulatory adherence and leading audit preparation and execution.
GS
Hybrid Senior Regulatory Specialist, Established Products, Global Labelling
Posted 2 months ago
About the role
- Senior Regulatory Specialist contributing to global regulatory labelling activities for established products. Collaborating with cross-functional teams to ensure compliance and deliver high-quality labelling documents at GSK.
Responsibilities
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and deliver high-quality labelling documents.
- Maintain and update the Company Core Datasheet / Global Datasheet (CCDS/GDS), EU PI (CP/MRP/DCP), and Medical Device product labels.
- Lead the discussion at Labelling Review Team (LRT) around the proposed wording for the CCDS/GDS and centrally managed PIs and seek agreement with all stakeholders involved.
- Support the Local Operating Companies (LOC) in the implementation of Global PI text into country PI, and authoring and coordinating responses to labelling questions from regulatory agencies.
- Take accountability for relevant labelling sections of the periodic aggregate reports.
- Represent Global Labelling in the Regulatory Matrix Team (RMT), the Safety Review Team (SRT) and Product Investigation Review Committee (PIRC) and internal audits.
- Represent GSK Global Labelling in inspections or meetings with regulatory authorities and external events (conferences/seminars, etc.)
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field.
- Experience in in pharmaceutical industry, life sciences research or regulatory.
- Understanding of the pharmaceutical industry, drug development environment and regulatory processes.
- Excellent English written and verbal communication skills.
- Detail-oriented with strong organizational and time management skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Master’s or PhD degree in a relevant field (preferred).
- Preferred experience in labelling or regulatory affairs.
- Proven ability to adapt to changing priorities and provide innovative solutions.
- Knowledge of Polish language is a plus.
- Experience with digital tools and platforms used in regulatory labelling.
Benefits
- Career at one of the leading global healthcare companies
- Hybrid work ( 2/3 days per week from the office)
- Contract of employment
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
- Life insurance and pension plan
- Private medical package with additional preventive healthcare services for employees and their eligible
- Sports cards (Multisport)
- Possibilities of development within the role and company’s structure
- Personalized learning approach.
- Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
- Supportive community and integration events
- Modern office with creative rooms, fresh fruits every day
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