Trade Compliance Manager overseeing trade compliance and logistics operations for NXP in Malaysia. Ensuring adherence to regulations and leading supply chain security initiatives.
GS
Hybrid Senior Regulatory Specialist, Established Products, Global Labelling
Posted 4 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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