Regulatory Affairs Manager/Senior Manager – CMC & Regulatory Change Management - FSP

Education and Experience Requirements

• Bachelor's degree or equivalent in a relevant scientific discipline; Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences or related disciplines preferred.
• 8+ years of directly relevant Regulatory Affairs experience, with a strong CMC background.
• Strong experience with EU/EEA clinical trial regulatory requirements and CMC regulatory documentation.
• Practical experience performing regulatory change assessments, including assessing the impact of CMC, manufacturing, supply or labelling changes.
• Experience determining whether changes require substantial or non-substantial modification under applicable EU clinical trial requirements.
• Experience supporting EU Clinical Trials Regulation submissions.
• Strong CMC authoring and review expertise, including experience with simplified IMPDs or comparable CMC documentation.
• Experience with pharmaceutical manufacturing, commercial medicinal products, clinical supplies and/or quality documentation preferred.
• Experience working directly with clients and coordinating activities across multiple functions and stakeholders preferred.

Equivalent combinations of education, training and directly related experience may also be considered.

Knowledge, Skills and Abilities

• Strong knowledge of EU/EEA clinical trial and CMC regulatory requirements.
• Ability to interpret regulatory requirements and translate them into clear, practical and defensible regulatory assessments.
• Strong analytical skills and ability to compare complex documentation and identify regulatory impact.
• Excellent organizational, planning and change-management skills, with the ability to manage multiple activities and dependencies concurrently.
• Strong process-oriented mindset, with the ability to bring structure to evolving activities and define effective ways of working.
• Excellent client and stakeholder management skills, including patience, resilience and professionalism.
• Proactive approach with the ability to work independently, exercise sound judgement and drive activities to completion.
• Excellent written and spoken English and strong attention to detail.
• Strong Microsoft Word and Excel skills, including document review, formatting and version comparison.
• Ability to work effectively across Regulatory Affairs, CMC, Quality, Labelling, Clinical Supplies and other functions.
• Comfortable working in a changing and evolving environment.

Working Conditions

• Remote/home-based working may be available from an eligible European location.
• Regular client interaction, including participation in weekly client meetings, is preferred.
• Ability to attend approximately monthly onsite meetings in the Basel, Switzerland area is expected.
• Occasional additional travel may be required.