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Company
MerckPlace(s)
ParisRegulatory Business Partner (m/f), Paris
Permanent
Pharmaceutical industry
Officer
Engineer
Engineer
Published 8 days
Merck
Merck - avec plus de 300 ans de progrès et plus de 38000 employés dans le monde, se positionne en leader sur le marché Pharmaceutique, Chimique, et des Sciences de la vie. Avec passion, engagement et innovation, nous poursuivons un objectif commun : améliorer la qualité de vie. C'est pourquoi nous avons besoin de vous!
Your role
- We are seeking a motivated and knowledgeable Regulatory Business Partner specializing in Electrical and Electronic Equipment (EEE) to join our Regulatory Business Transformation team. This role will support our Life Sciences business by defining and executing regulatory and compliance strategies associated with projects related to our EEE product portfolio. You will act as a Subject Matter Expert (SME) on EEE topics, ensuring compliance with global regulatory requirements for the launch of new products while collaborating closely with internal and external stakeholders.
Key Responsibilities
- Regulatory Guidance: Provide expert guidance on global regulatory requirements related to EEE, including Safety, Electromagnetic Compatibility (EMC), RoHS, WEEE, REACH, and other applicable standards.
- Project Execution: Define and execute regulatory and compliance strategies for EEE projects, ensuring alignment with business objectives.
- Stakeholder Collaboration: Develop and manage stakeholder communication, fostering strong relationships with internal teams and external partners to facilitate clear understanding of regulatory requirements.
- Information Flow Management: Oversee information flow throughout the value chain, ensuring all regulatory aspects are integrated into project plans.
- Change Management: Emphasize change management practices to support the successful implementation of regulatory strategies and initiatives.
- Risk Assessment: Conduct risk assessments related to regulatory compliance and develop strategies to mitigate identified risks.
- Resource Management: Manage resources effectively to ensure timely delivery of key results and project objectives.
- Continuous Improvement: Identify opportunities for continuous improvement in regulatory processes and strategies, promoting efficiency and effectiveness.
- Training and Development: Develop and deliver training programs for internal teams on EEE regulatory requirements and best practices.
Profile
- Bachelor’s degree in a relevant field (e.g., Engineering, Environmental Science, Regulatory Affairs).
- Minimum of 5 years of experience in regulatory compliance, specifically related to EEE.
- Strong understanding of global regulatory frameworks and standards for EEE.
- Excellent analytical and problem-solving skills.
- Strong communication and interpersonal skills, with the ability to work collaboratively in a cross-functional environment.
- Proven ability to manage multiple projects and meet deadlines.
- Experience in a multinational company or in a regulatory role within the EEE sector.
- Familiarity with product lifecycle management and regulatory submission processes.
- Certification in Regulatory Affairs (e.g., RAC) is a plus.
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