Regulatory Compliance Officer
As a Regulatory Compliance Officer based in Nyon, you will coordinate all activities with a regulatory impact on a portfolio of products, participate in submission strategy, follow up variations and perform implementation of changes in production and release systems in order to ensure regulatory compliance
Your responsibilities include in detail:
- Act as point of contact for the plant to coordinate product related requests with a regulatory impact from LOC, production or any other department.
- Review and approve all product related information (main CTD dossier sections: formula, manufacturing process, specifications & methods, statements, TIs, BOMs).
- Verify compliance of locally approved dossiers with plant practices for NPIs and approve system setup before launches.
- Participate in Site Change Control Committee, through impact assessment, implementation strategy in compliance with both GMPs and registration documentation.
- Verify regulatory compliance of locally registered dossiers vs global dossiers (module 3) vs plant practices
- Identify and evaluate gaps and propose regulatory remediation implementation strategy in agreement with global regulatory affairs
- Follow up change controls and ensure timely implementation
- Ensure alignment between SMEs, LOCs and CMC in order to close HA Commitments within agreed timelines.
- Get escalation process under way in case of non-compliance
- Apply and support GSK HSE requirements
- Anticipate change consequences on health, security and environment
- Enforce and drive GMP standards
- GMP knowledge and experience to support the requirements expected by Swissmedic, European union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system
- Provide all necessary support during HA inspections
- Regular reports on KPIs in relation to activities
- Communicate with ease with local affiliates and with internal departments
As a successful Regulatory Compliance Officer, you have an excellent level of communication and you are recognized for your adaptability and your precision to work in a challenging environment.
Furthermore you display the following qualifications and competencies:
- Bachelor in Life Sciences with proficiency in English or equivalent
- Minimum 3 years' experience in a Pharmaceutical Regulatory/Quality Environment.
- Strong knowledge of Module 3 / CMC chemistry manufacturing Control
- Driven for accurate and detailed results, while exercising good judgement.
- Striving for continuous Improvement in the systems and processes supporting regulatory compliance
- Fluent in French and English (oral and written)
- MS Office : good command
You may apply for this position online by selecting the Apply now button.
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