Regulatory Affairs Manager

• Bachelor's Degree in Life Sciences or a related discipline required

• Master's Degree in Life Sciences or a related discipline preferred

Individual contributor with advanced knowledge acquired from at least 8 years of relevant industry experience. Working independently with limited supervision, the individual will provide strategic regulatory expertise and leadership for clinical trial applications and lifecycle management activities, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and Clinical Trials Information System (CTIS) management.

• Act as Regulatory Global Team Leader for regulatory projects and/or serve as Regulatory Project Manager for stand-alone projects

• Lead the preparation, review, and submission of regulatory documentation, ensuring high quality and compliance with applicable regulations and guidelines

• Provide strategic regulatory advice to clients, including EU submission strategy, Reporting Member State (RMS) selection, scientific advice planning, and lifecycle management activities

• Lead and support EU CTR submissions, including initial CTA submissions, substantial modifications, Requests for Information (RFIs), and CTIS lifecycle activities

• Manage communications and interactions with regulatory authorities, including support for and participation in agency meetings.

• Build and maintain strong client relationships, acting as a trusted advisor on regulatory matters and proactively resolving issues

• Manage project timelines, deliverables, budgets, and out-of-scope activities to ensure successful project execution and financial performance

• Mentor and provide guidance to junior colleagues, including review of regulatory documentation and support for training and professional development

• Support business development activities, including travelling to and participating in bid defense meetings and client presentations

• Contribute to the development, revision, and review of regulatory and cross-functional Standard Operating Procedures (SOPs)

• Support global, regional, and cross-functional regulatory initiatives and process improvement activities

• Remain current with regulatory intelligence, evolving regulations, and industry best practices

• Perform additional duties as assigned to support business and departmental objectives

• Minimum of 8 years of regulatory affairs experience within the pharmaceutical, biotechnology, CRO, or related industry

• Minimum of 2 to 3 years of hands-on EU CTR and CTIS experience, including preparation, review, and submission of Part I initial Clinical Trial Applications (CTAs)

• Demonstrated experience managing CTIS lifecycle activities, including RFIs, substantial modifications, and ongoing trial maintenance

• Experience interacting with Reporting Member States (RMS) and other European regulatory authorities

• Proven experience advising clients on EU regulatory strategy, including RMS selection, submission planning, and scientific advice strategy

• Advanced understanding of EU clinical trial regulations, guidance documents, and CTIS requirements

• Strong understanding of regulatory documentation requirements across different therapeutic areas, development stages, and product modalities

• Experience with combination product trials is advantageous

• Experience in regulatory strategy development, timeline planning, budget management, and documentation gap assessments

• Ability to independently manage multiple projects and priorities while meeting challenging timelines

• Strong project leadership and stakeholder management skills

• Excellent written and verbal communication skills, including preparation of high-quality regulatory documents and client-facing presentations

• Ability to establish and maintain effective relationships with clients, colleagues, and regulatory authorities

• Proficiency in Microsoft Office and relevant regulatory systems and publishing tools

• Applicable certifications and licenses as required by local regulations and business needs

• Willingness to support cross-functional and global initiatives as required