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Regulatory Affairs Manager

2 months ago

London, Greater London, United Kingdom Novartis Farmacéutica Full time
About the Role

The Senior Regulatory Affairs Manager is a key member of the Novartis team, responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.

Key Responsibilities
  • Regulatory Strategy and Planning: Develop and implement regulatory strategies to ensure compliance with regulatory requirements and optimize business outcomes.
  • Submission and Maintenance: Prepare and submit regulatory documents, including marketing authorizations, labels, and packaging materials, to ensure timely and accurate submissions.
  • Regulatory Advice and Support: Provide regulatory advice and support to cross-functional teams, including business development, marketing, and sales, to ensure informed decision-making and optimal business outcomes.
  • Regulatory Compliance: Ensure compliance with regulatory requirements, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
  • Collaboration and Communication: Collaborate with internal stakeholders, including regulatory affairs, quality assurance, and compliance, to ensure effective communication and coordination of regulatory activities.
  • Regulatory Training and Development: Provide training and development opportunities to regulatory affairs staff to ensure they have the necessary skills and knowledge to perform their roles effectively.
Requirements
  • Education: Bachelor's degree in a life science or related field.
  • Experience: Minimum 5 years of experience in regulatory affairs, with a strong background in regulatory strategy, submission, and compliance.
  • Skills: Strong knowledge of regulatory requirements, including GMP, GLP, and GCP. Excellent communication and collaboration skills. Ability to work in a fast-paced environment and prioritize multiple tasks and deadlines.