CMC Regulatory Lead - Remote

Overview

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

In Short

• Drive the global, risk-based CMC regulatory strategy for several complex life-cycle changes to marketed products.
• Act as the CMC regulatory point of contact within cross-functional project teams (Manufacturing, Quality, Supply, MSAT, etc.)
• Assess the regulatory impact of manufacturing changes and propose clear strategic recommendations.
• Coordinate the preparation and submission of CMC regulatory dossiers worldwide (post-AMM).
• Anticipate regulatory risks and define mitigation plans adapted to country/health authority requirements.
• Respond to questions from health agencies on CMC issues, in collaboration with technical functions.
• Manage all CMC regulatory responsibilities for the assigned sales portfolio, including associated pharmaceutical responsibilities.
• Monitor regulatory developments (ICH, FDA, EMA) and integrate them into proposed strategies.
• Actively participate in continuous CMC process improvement initiatives within the function.
• Work in an international environment and in close interaction with multidisciplinary global teams.

Requirements

• Experience in CMC regulatory affairs.
• Strong understanding of regulatory requirements in pharmaceutical industry.
• Ability to work collaboratively in cross-functional teams.
• Excellent communication and interpersonal skills.
• Proven track record in managing regulatory submissions.
• Ability to anticipate regulatory risks and propose solutions.
• Familiarity with international regulatory agencies (ICH, FDA, EMA).
• Experience in process improvement initiatives.
• Strong analytical and strategic thinking skills.
• Fluency in English; knowledge of additional languages is a plus.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Inclusive and collaborative work environment.
• Engagement in innovative projects in the clinical research space.
• Work with a dynamic and ambitious team.
• Flexible working arrangements.
• Access to training and development resources.
• Health and wellness programs.
• International work experience.
• Contribution to meaningful projects that impact healthcare.